MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
FDA 510(k) clearance K070001 · decided 2007-02-02
Clearance details
- K-number
- K070001
- Device name
- MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE
- Applicant
- Mti Precision Products
- Decision
- Substantially Equivalent
- Date received
- 2007-01-03
- Decision date
- 2007-02-02
- Days to decision
- 30 days
- Clearance type
- Special
- 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
No recalls on record reference this clearance.