What FDA Clearance Means for Dental AI Software

FDA clearance for dental AI software usually means a 510(k) clearance: the FDA found the device substantially equivalent to a device already legally on the US market, for the use written in its Indications for Use statement. Clearance covers that stated use only, often specific image types and patient ages. It is a different decision from PMA approval. If you’re buying AI that reads radiographs, you need to know which pathway a tool went through, how to read its clearance, which practice software sits outside the FDA’s device definition, how to look a device up and what to ask the vendor.

What does “FDA cleared” mean for dental AI software?

“FDA cleared” means the FDA sent the maker a letter finding the device substantially equivalent to a legally marketed device, called the predicate, and stating that it can be marketed in the US. The FDA’s 510(k) page says this order “clears” the device for commercial distribution. Most dental AI tools on our site reached the market this way.

Substantial equivalence, as the FDA defines it, means the same intended use as the predicate plus either the same technological characteristics, or different ones that don’t raise different questions of safety and effectiveness, with data showing the new device is as safe and effective. Identical devices aren’t required. According to the FDA, the data it reviews can include clinical data and bench testing, software validation among them.

Three more points from the FDA’s 510(k) page matter when you buy:

• The FDA says the substantial equivalence decision is usually made within 90 days, based on the information the submitter sends.
• Before clearance, the FDA does not typically inspect the maker’s facility. After it, the maker should be ready for a quality system inspection at any time.
• The FDA says a new 510(k) is required when modifications “could significantly affect the safety or effectiveness of the device”, or when the device will be marketed for a new or different intended use. This is one reason a single vendor can hold many clearances.

You can see this in the FDA 510(k) entries we keep for each tool. Overjet, for example, has 12 entries in our data, each for a separate device, from Overjet Dental Assist (K210187, May 19, 2021) to Overjet Multi-Image Caries and Charting Assist (K261059, August 6, 2026). You can read the full list in our Overjet review.

How are 510(k) clearance, De Novo and PMA approval different?

The FDA uses three main premarket pathways, and each has its own word: a 510(k) is “cleared”, a De Novo request is “granted” and a PMA is “approved”. “Cleared” and “approved” are separate FDA decisions, so a vendor that says the FDA “approved” a 510(k) device is using the wrong word.

• 510(k) clearance. A maker compares its device to a predicate and shows substantial equivalence. The FDA’s 510(k) page says this applies to devices for which a premarket approval application (PMA) is not required.
• De Novo classification. The FDA says the De Novo request is a pathway for novel devices that have no legally marketed predicate, where general controls, or general and special controls, give reasonable assurance of safety and effectiveness. Once a request is granted, the FDA creates a new classification regulation, and the device can then serve as a predicate for future 510(k) submissions. De Novo numbers start with “DEN” or “BR”, and the FDA’s stated goal is a decision within 150 review days.
• PMA approval. The FDA calls premarket approval “the most stringent type of device marketing application”. It applies to Class III devices, which the FDA describes as those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Approval rests on the FDA finding “sufficient valid scientific evidence” that the device is safe and effective for its intended use.

All four tools in this guide hold 510(k) clearances in our data, and none has a De Novo or PMA entry there. That fits the FDA’s own description of the pathways: its device-determination page says most Class II (moderate risk) devices need 510(k) clearance and most Class III (high risk) devices need PMA.

What is an Indications for Use statement, and why does it matter?

An Indications for Use statement is the part of an FDA clearance that says what the device is for. In the FDA’s words, indications for use describe the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including the patient population it is intended for; intended use is the device’s general purpose or function. A clearance covers what that statement says. A vendor’s website can describe a lot more.

When you read one of these statements, look for four things: the finding (caries, periapical radiolucency, bone levels), the image type (bitewing, periapical, panoramic, CBCT), the patient age range, and how the dentist uses it (as a concurrent reader, a second reader, or both). The four tools we track show how much those details vary.

Diagnocat: one finding on CBCT

Diagnocat’s only clearance in our data (K252934, January 15, 2026) covers software that aids in detecting periapical radiolucency on permanent teeth in maxillofacial CBCT images, as a second read, for patients 22 years of age or older. The statement also says users should have at least two years of clinical experience reading CBCT scans, and that the device is not intended as a replacement for a dental professional’s complete review or clinical judgment.

Diagnocat’s homepage describes much more: AI analysis of intraoral X-rays, panoramic radiographs and CBCT scans, and the vendor says it detects more than 60 conditions on 3D scans and over 40 on 2D images. The same site says regulatory clearance or approval varies by country and asks readers to contact the company to confirm availability in their region. For a US practice, the clearance is what tells you the FDA-reviewed use. Our Diagnocat review covers the rest.

Overjet: the same product name, cleared again for more images and ages

Overjet Caries Assist shows how a cleared use can grow through new 510(k)s. The first clearance (K212519, May 10, 2022) covers caries on bitewing radiographs in patients with permanent dentition who are at least 18 years of age. A later one (K222746, March 27, 2023) covers bitewing and periapical radiographs in patients 12 years of age or older. A separate device, Overjet Caries Assist-Pediatric (K233738, March 4, 2024), covers patients aged 4 to 11. Overjet’s homepage describes its Vision AI as “FDA-cleared AI for comprehensive diagnosis & patient education”; each clearance letter is narrower and names one task.

Pearl Second Opinion: one brand, different age limits

Pearl’s Second Opinion name appears on eight clearances in our data, and the age ranges differ between them. The original Second Opinion (K210365, March 4, 2022) covers bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older. Second Opinion CC (K242522, January 16, 2025), for caries, starts at 19 years of age or older, while Second Opinion Panoramic (K250525, November 14, 2025) covers panoramic radiographs in patients 16 years of age or older. For children, Second Opinion Pediatric (K243893, May 5, 2025) covers patients aged 4 years and older. So the clearance that applies depends on the module you buy. Details are in our Pearl Second Opinion review.

Videa: a narrow first clearance, broader later ones

Videa Caries Assist (K213795, April 21, 2022) is indicated for board licensed dentists reviewing bitewing radiographs from adult patients aged 22 years or older. VideaHealth’s later Videa Dental Assist (K232384, December 15, 2023) covers bitewing, periapical and panoramic radiographs from patients aged 3 years or older and lists many more findings. The two clearances have different names, so when a sales rep says “Videa is cleared”, ask which device that means. Our Videa Caries Assist review lists all four VideaHealth entries.

None of these statements describes a tool that diagnoses on its own. Several, including Overjet’s and Diagnocat’s, say in plain terms that the device is not a replacement for the dentist’s review or clinical judgment.

Is scheduling, phone and billing software regulated by the FDA?

Much administrative software is outside the FDA’s device definition, according to the FDA. Its Digital Health Policy Navigator says software functions intended for administrative support of a health care facility are not devices under section 520(o) of the FD&C Act. The law it quotes lists examples, including processing claims or billing information, appointment schedules, business analytics, and practice and inventory management.

A separate FDA list of software functions that are not medical devices gives similar examples: apps that determine billing codes, process insurance claims, perform medical business accounting, or generate reminders for scheduled appointments. The FDA says it does not regulate these because they are not medical devices.

That answer has limits:

• Each software function is looked at on its own. The navigator tells makers to go back to step 1 for each additional function a product contains. A platform can include both an administrative function and a device function, and the second one is still a device.
• The FDA pages we saved name scheduling, reminders, billing and claims. They don’t mention phone systems or AI receptionists by name, so we can’t tell you where the FDA puts them.
• Even here, the FDA’s wording is “likely not a device”, and it points makers with doubts to its Digital Health inbox. If you’re unsure about a specific product, ask the vendor how it has classified each function, and ask a regulatory professional if it matters to your decision.

Some vendors sell both kinds of software. Overjet’s website, for example, also markets revenue cycle and voice products, and the 12 Overjet entries in our FDA data are all imaging devices. We don’t know how the FDA would view those other products, so we make no claim about them.

How do you look up a device in the FDA’s 510(k) database?

You can check any clearance yourself in the FDA’s free 510(k) Premarket Notification database. Search by 510(k) number if the vendor gives you one, or by applicant name or device name. Then open the entry and read the decision document, where the Indications for Use statement is.

1. Open the FDA’s 510(k) Premarket Notification database (linked in Sources).
2. Enter the 510(k) number (for example K252934) or the applicant name. The applicant may differ from the brand: Diagnocat’s clearance lists the applicant as DGNCT, LLC.
3. If you search by panel, search both Radiology and Dental. For the four tools in this guide, every entry sits under the Radiology panel, and three product codes cover them: MYN, QIH and LLZ. Other dental software can be listed under the Dental panel: SoftSmile Vision, aligner planning software from Softsmile, Inc., is cleared under K212770 (December 21, 2021) in the Dental panel with product code PNN.
4. Check the decision date and the device name, then open the decision document and find the Indications for Use.
5. Compare the image types, findings and patient ages in that statement with the features you’re being sold.

From the same search page you can reach the FDA’s De Novo and PMA databases. The FDA also publishes a list of AI-enabled medical devices authorized for marketing in the US, which includes devices from Overjet, Pearl, VideaHealth and Diagnocat. The FDA says that list is not comprehensive and that the database summaries are not all-inclusive, so treat the 510(k) entry as the record.

What to ask a dental AI vendor about FDA clearance

Ask for the specific FDA numbers, then compare each one with the features you’ll use. Start with these:

• Which 510(k), De Novo or PMA numbers cover the features we’ll use? A brand name can sit on several clearances, each for a different task.
• Which image types and patient ages does each clearance cover? Our data has clearances limited to bitewings only, to patients 22 and older, and to children aged 4 to 11.
• Which features in your demo are not covered by a US clearance? Diagnocat’s homepage advertises analysis of 2D and 3D images; its clearance covers periapical radiolucency on CBCT.
• Who is the applicant on the clearance? It helps you find the entry, and it tells you who holds the clearance.
• Is it cleared as a concurrent reader, a second reader, or both? The Indications for Use says how the dentist is meant to use the output.
• Where does your accuracy figure come from? Pearl’s product page says Second Opinion achieves over 95% accuracy. Ask any vendor for the study behind a figure like that, with its size and setting.
• Which of your other products, such as scheduling, billing or notes, are not FDA devices, and how did you decide? The FDA looks at each software function separately.

A clearance letter tells you the use the FDA reviewed. Fit with your office, pricing and support are questions for the vendor, and questions about your own legal or regulatory duties are for a professional.

FAQ

Sources

1. FDA: Premarket Notification 510(k), accessed October 20, 2026
2. FDA: De Novo Classification Request, accessed October 20, 2026
3. FDA: Premarket Approval (PMA), accessed October 20, 2026
4. FDA: 510(k) Premarket Notification database, accessed October 20, 2026
5. FDA: How to Determine if Your Product is a Medical Device, accessed October 20, 2026
6. FDA Digital Health Policy Navigator: Step 2, Is the Software Function Intended for Administrative Support of a Health Care Facility?, accessed October 20, 2026
7. FDA: Examples of Software Functions That Are NOT Medical Devices, accessed October 20, 2026
8. FDA: List of Artificial Intelligence-Enabled Medical Devices, accessed October 20, 2026
9. FDA 510(k) database: K252934, Diagnocat, accessed October 19, 2026
10. FDA 510(k) database: K212519, Overjet Caries Assist, accessed October 19, 2026
11. FDA 510(k) database: K222746, Overjet Caries Assist, accessed October 19, 2026
12. FDA 510(k) database: K233738, Overjet Caries Assist-Pediatric, accessed October 19, 2026
13. FDA 510(k) database: K210365, Second Opinion, accessed October 19, 2026
14. FDA 510(k) database: K242522, Second Opinion CC, accessed October 19, 2026
15. FDA 510(k) database: K250525, Second Opinion Panoramic, accessed October 19, 2026
16. FDA 510(k) database: K243893, Second Opinion Pediatric, accessed October 19, 2026
17. FDA 510(k) database: K213795, Videa Caries Assist, accessed October 19, 2026
18. FDA 510(k) database: K232384, Videa Dental Assist, accessed October 19, 2026
19. FDA 510(k) database: K210187, Overjet Dental Assist, accessed October 19, 2026
20. FDA 510(k) database: K261059, Overjet Multi-Image Caries and Charting Assist, accessed October 19, 2026
21. FDA 510(k) database: K212770, SoftSmile Vision, accessed October 20, 2026
22. Diagnocat homepage, accessed October 19, 2026
23. Overjet homepage, accessed October 19, 2026
24. Pearl: Second Opinion product page, accessed October 19, 2026