Prosthetic devices · 21 CFR 872 Subpart D
Endodontic Kit
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Companies listing it
- 86 makers
- Brands and models
- 3
- 510(k) clearances
- 00 in five years
- FDA name
- Endodontic Kit
Companies that list NYD
8 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Terauchi File Removal Kit | 12 | 2025 |
| Denjoy Dental Co., Ltd. | China | Maker | JAS Unit Endo System plus JAS Pack Gutta-Percha Cutter | 1 | 2025 |
| Dental Engineering Laboratories | United States | Maker | TFRK | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
Official records: FDA product classification for NYD · 21 CFR 872.3820.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026