Clearance Summary
ENDOGATOR received FDA 510(k) clearance under submission number K770813, sponsored by Aus-Tex Dental Mfg. & Design. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-05-20.
- Submission: K770813
- Applicant / Sponsor: Aus-Tex Dental Mfg. & Design
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1977-05-20
Classification & Regulation
This clearance is catalogued under FDA product code EIC and 21 CFR 872.4565, within the Dental review panel as a Class I device.