Clearance Summary
ACETAL DENTAL/PREFORMED CLASP received FDA 510(k) clearance under submission number K954971, sponsored by B & H Technical Services , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-12-11.
- Submission: K954971
- Applicant / Sponsor: B & H Technical Services , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3285
- Decision date: 1995-12-11
Classification & Regulation
This clearance is catalogued under FDA product code EHP and 21 CFR 872.3285, within the Dental review panel as a Class I device.