510(k) K162544
- Device
- OsteoMed PINNACLE Driver
- Applicant
- OSTEOMED
- 510(k) number
- K162544
- Product code
- KMW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-04
- Date received
- 2016-09-12
- Regulation
- 872.4120
- Classification name
- Handpiece, Rotary Bone Cutting
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATHRYN A. JAYNE
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
FDA Registration Numbers#
- 3009161350
- 1422375
- 3014683120
- 1649518
- 3014953747
- 3030126955
- 3030235916
- 3006540014
- 3011276344
- 9681479
- 3007279848
- 2027754
- 3011824442
- 9611253
- 3011300255
- 1054713
- 3010185635
Source Documents#
Other 510(k) Records For Product Code KMW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | 2021-08-19 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017-11-21 |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | 2008-07-29 |
| K994298 | FRIOS MICROSAW | Friadent GmbH | 2000-02-18 |
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Osteomed Corp. | 1997-06-27 |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Nsk Nakanishi, Inc. | 1997-04-15 |
| K932255 | YOUNG D'GRANULATOR | Young Dental Manufacturing Co. 1, LLC | 1994-04-15 |
| K862110 | OSSEODENT DRILLING SYSTEM | Otc/America | 1986-08-07 |
Legacy Summary#
summary
FDA Review#
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