Endodontic Kit
FDA product code NYD · Class II (moderate risk) · 21 CFR 872.3820 · Dental
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.
0510(k) clearances
0PMA approvals
1recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0494-2023 Class II | Surgical room, Implant Pack, Item No.41111UTI, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… | Stradis Medical, LLC dba Stradis Healthcare | 11/02/2022Open, Classified |