Clearance Summary
CREMEEN ALVEOLAR BONE CALIPER received FDA 510(k) clearance under submission number K872098, sponsored by Bowen & Company, 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 1987-07-31.
- Submission: K872098
- Applicant / Sponsor: Bowen & Company, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1987-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EIL and 21 CFR 872.4565, within the Dental review panel as a Class I device.