Clearance Summary
PEMACO BITE WAX SHEETS received FDA 510(k) clearance under submission number K895563, sponsored by Pemaco, 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 1989-11-06.
- Submission: K895563
- Applicant / Sponsor: Pemaco, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6890
- Decision date: 1989-11-06
Classification & Regulation
This clearance is catalogued under FDA product code EGD and 21 CFR 872.6890, within the Dental review panel as a Class I device.