Handpiece, Belt And/Or Gear Driven, Dental
Regulation 872.4200
0510(k)s in 12 months (25 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Anthogyr | 3 | 0 |
| Dentalez Group | 3 | 0 |
| Kaltenbach & Voigt GmbH | 3 | 0 |
| Dentsply Intl. | 2 | 0 |
| J. Morita USA, Inc. | 2 | 0 |
| Amc General, Inc. | 1 | 0 |
| Cranston Ind., Inc. | 1 | 0 |
| Dental EZ Group Star Dental Division | 0 | 1 |
| Dental EZ Stardental Division | 0 | 1 |
| Dpm USA Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2014 | Dental EZ Group Star Dental Division Titan T 5K Motor
Product Usage:
Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The Terminated |
EFA | K960260 |
| Sep 2, 2010 | Dental EZ Stardental Division Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free Terminated |
EFA | K960260 |
| Dec 27, 2006 | Stardental Division Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900. Terminated |
EFA | K960507 K960719 |
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