Clearance Summary
ARCEE DENTAL POST received FDA 510(k) clearance under submission number K851038, sponsored by Arcee Dental Products 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 1985-04-29.
- Submission: K851038
- Applicant / Sponsor: Arcee Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3810
- Decision date: 1985-04-29
Classification & Regulation
This clearance is catalogued under FDA product code ELR and 21 CFR 872.3810, within the Dental review panel as a Class I device.