LYNX LOW-SPEED HANDPIECE
FDA 510(k) clearance K940261 · decided 1994-12-29
Clearance details
- K-number
- K940261
- Device name
- LYNX LOW-SPEED HANDPIECE
- Applicant
- Mti Precision Products
- Decision
- Substantially Equivalent
- Date received
- 1994-01-21
- Decision date
- 1994-12-29
- Days to decision
- 342 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lakewood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products recall (Z-2044-2014) | MTI Precision Products LLC. | 2014-07-12 |