FDA product code NDP: Accessories, Implant, Dental, Endosseous
NDP is the FDA product code for accessories, implant, dental, endosseous. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under NDP, from 2 different applicants. The average 510(k) review took 172 days (median 172). FDA has posted 57 recalls for NDP devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Implant, Dental, Endosseous |
| Device class | Class I |
| Regulation | 21 CFR 872.3980 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for NDP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 85 |
| 2019 | 1 | 259 |
| 2020 | 1 | 268 |
Compare with all 510(k) review times · Search every NDP clearance
Top NDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dentsply Sirona | 3 | 2020-09-02 |
| Thommen Medical AG | 1 | 2007-04-17 |
Most recent NDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193405 | Dentsply Sirona | Simplant Digital Guide | 2020-09-02 | 268 |
| K190059 | Dentsply Sirona | CEREC Guides | 2019-09-27 | 259 |
| K170849 | Dentsply Sirona | SIMPLANT Guide | 2017-06-15 | 85 |
| K070290 | Thommen Medical AG | SPI VECTODRILL CERAMIC DRILLS | 2007-04-17 | 77 |
Recalls for NDP devices
57 product recalls in 33 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2026-01-06.
| Year | Recalls |
|---|---|
| 2017 | 10 |
| 2018 | 5 |
| 2019 | 9 |
| 2021 | 7 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NDP?
NDP is the FDA product code for accessories, implant, dental, endosseous. It is a Class I device, regulated under 21 CFR 872.3980 and reviewed by the Dental panel.
What device class is NDP?
Class I, regulation 21 CFR 872.3980. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NDP?
Across 4 cleared submissions the average was 172 days from receipt to decision (median 172).
Which companies have the most NDP clearances?
Dentsply Sirona (3); Thommen Medical AG (1).
Have NDP devices been recalled?
Yes: 57 product recalls across 33 recall events; the most recent began 2026-01-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NDP
- Run a recall and safety report across every NDP manufacturer
- Watch product code NDP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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