Clearance Summary
OPALDAM received FDA 510(k) clearance under submission number K971284, sponsored by Ultradent Products, 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 1997-06-03.
- Submission: K971284
- Applicant / Sponsor: Ultradent Products, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1997-06-03
Classification & Regulation
This clearance is catalogued under FDA product code EIG and 21 CFR 872.4565, within the Dental review panel as a Class I device.