Clearance Summary
BRACE (ORAFIX SPECIAL) received FDA 510(k) clearance under submission number K890290, sponsored by Norcliff Thayer, 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 1989-03-29.
- Submission: K890290
- Applicant / Sponsor: Norcliff Thayer, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-03-29
Classification & Regulation
This clearance is catalogued under FDA product code ECB and 21 CFR 872.4565, within the Dental review panel as a Class I device.