Clearance Summary
FIXTECTOR received FDA 510(k) clearance under submission number K864572, sponsored by Prodent Intl., 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 1987-02-12.
- Submission: K864572
- Applicant / Sponsor: Prodent Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6140
- Decision date: 1987-02-12
Classification & Regulation
This clearance is catalogued under FDA product code EFH and 21 CFR 872.6140, within the Dental review panel as a Class I device.