Handpiece, Rotary Bone Cutting
Regulation 872.4120
0510(k)s in 12 months (9 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in KMW
| Company | 510(k)s | Recalls |
|---|---|---|
| Nakanishi, Inc. | 2 | 8 |
| Osteomed | 2 | 1 |
| W&H Dentalwerk Buermoos GmbH | 1 | 1 |
| Friadent GmbH | 1 | 0 |
| Nsk Nakanishi, Inc. | 1 | 0 |
| Otc/America | 1 | 0 |
| Young Dental Manufacturing Co. 1, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2021 | K211584 | Oral Surgery Contra Nakanishi, Inc., JP | KMW |
| Nov 21, 2017 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece Nakanishi, Inc., JP | KMW |
| Apr 4, 2017 | K162544 | OsteoMed PINNACLE Driver Osteomed | KMW |
| Jul 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES W&H Dentalwerk Buermoos GmbH, AT | KMW |
| Feb 18, 2000 | K994298 | FRIOS MICROSAW Friadent GmbH | KMW |
| Jun 27, 1997 | K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES Osteomed Corp. | KMW |
| Apr 15, 1997 | K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE Nsk Nakanishi, Inc., JP | KMW |
| Apr 15, 1994 | K932255 | YOUNG D'GRANULATOR Young Dental Manufacturing Co. 1, LLC | KMW |
| Aug 7, 1986 | K862110 | OSSEODENT DRILLING SYSTEM Otc/America | KMW |
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