NDP
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Accessories, Implant, Dental, Endosseous
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3980
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2021: 237 · 2022: 188 · 2023: 212 · 2024: 224 · 2025: 390 · 2026: 2,396
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Simplant Digital Guide (K193405) | Dentsply Sirona | 2020-09-02 |
| CEREC Guides (K190059) | Dentsply Sirona | 2019-09-27 |
| SIMPLANT Guide (K170849) | Dentsply Sirona | 2017-06-15 |
| SPI VECTODRILL CERAMIC DRILLS (K070290) | Thommen Medical AG | 2007-04-17 |
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Every clearance here is in the API, with alerts when new ones post.