OsteoMed PINNACLE Driver
FDA 510(k) clearance K162544 · decided 2017-04-04
Clearance details
- K-number
- K162544
- Device name
- OsteoMed PINNACLE Driver
- Applicant
- Osteomed
- Decision
- Substantially Equivalent
- Date received
- 2016-09-12
- Decision date
- 2017-04-04
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- KMW
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Addison, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Oral Surgery Contra (K211584) | Nakanishi, Inc. | 2021-08-19 |
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |
| SURGICAL HANDPIECES, MIKRO SAW HANDPIECES (K080939) | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| FRIOS MICROSAW (K994298) | Friadent GmbH | 2000-02-18 |
| OSTEOPOWER SYSTEM AND ACCESSORIES (K971692) | Osteomed Corp. | 1997-06-27 |
| E-TYPE SPEED REDUCER CONTRA ANGLE (K970953) | Nsk Nakanishi, Inc. | 1997-04-15 |
| YOUNG D'GRANULATOR (K932255) | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 |
| OSSEODENT DRILLING SYSTEM (K862110) | Otc/America | 1986-08-07 |
Recalls involving this device
No recalls on record reference this clearance.