Clearance Summary
BITEM LOCK, MODELS SW006, SW012 received FDA 510(k) clearance under submission number K994357, sponsored by Thermoelastic Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2000-03-14.
- Submission: K994357
- Applicant / Sponsor: Thermoelastic Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.5410
- Decision date: 2000-03-14
Classification & Regulation
This clearance is catalogued under FDA product code EJF and 21 CFR 872.5410, within the Dental review panel as a Class I device.