Handpiece, Air-Powered, Dental
Regulation 872.4200
4510(k)s in 12 months (263 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in EFB
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Dec, Inc. | 19 | 0 |
| Nakanishi, Inc. | 10 | 1 |
| Dentsply Intl. | 8 | 0 |
| Micro Motors, Inc. | 7 | 0 |
| Dentalez, Inc. | 6 | 0 |
| E.M.S Electro Medical Systems S.A | 6 | 0 |
| J. Morita USA, Inc. | 5 | 0 |
| Midwest | 5 | 0 |
| Mti Precision Products | 4 | 1 |
| Nsk Nakanishi, Inc. | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2023 | Coltene Whaledent Inc SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing Open, Classified |
EFB | K071891 |
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)
The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the Terminated |
EFB | K962543 |
| Jul 12, 2014 | MTI Precision Products LLC. Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products Terminated |
EFB | K940261 |
| Dec 19, 2006 | Kavo America Corporation KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenanc Terminated |
EFB | K012308 |
| Jul 20, 2004 | DentSply -Professional Division Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des plaines, IL Terminated |
EFB | None listed |
| Jul 20, 2004 | DentSply -Professional Division Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 West Oakton Street, Des pla Terminated |
EFB | K963050 |
| Jul 20, 2004 | DentSply -Professional Division Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Professional, A Division of DENTSPLY Internatio Terminated |
EFB | K963050 |
| Jul 20, 2004 | DentSply -Professional Division Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International, 901 Terminated |
EFB | K963050 |
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