Clearance Summary
MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE received FDA 510(k) clearance under submission number K070001, sponsored by Mti Precision Products. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2007-02-02.
- Submission: K070001
- Applicant / Sponsor: Mti Precision Products
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2007-02-02
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.