E-TYPE SPEED REDUCER CONTRA ANGLE
FDA 510(k) clearance K970953 · decided 1997-04-15
Clearance details
- K-number
- K970953
- Device name
- E-TYPE SPEED REDUCER CONTRA ANGLE
- Applicant
- Nsk Nakanishi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-17
- Decision date
- 1997-04-15
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- KMW
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tochigi-Ken, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Oral Surgery Contra (K211584) | Nakanishi, Inc. | 2021-08-19 |
| Surgical Angle Handpiece, Surgical Straight Handpiece (K171155) | Nakanishi, Inc. | 2017-11-21 |
| OsteoMed PINNACLE Driver (K162544) | Osteomed | 2017-04-04 |
| 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 |
| 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.