Clearance Summary
CENTRIC (BITE) REGISTRATION PASTE received FDA 510(k) clearance under submission number K810498, sponsored by Wallace A. Erickson & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-03-17.
- Submission: K810498
- Applicant / Sponsor: Wallace A. Erickson & Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6140
- Decision date: 1981-03-17
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.