Clearance Summary
DOLOTENS DENTAL TM 1 received FDA 510(k) clearance under submission number K043373, sponsored by Neuromuscular Technologies, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2005-09-02.
- Submission: K043373
- Applicant / Sponsor: Neuromuscular Technologies, Inc.
- Clearance pathway: Abbreviated
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2005-09-02
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.