Clearance Summary
U-15 SINGLE END SCALER received FDA 510(k) clearance under submission number K901171, sponsored by American Medical Ceramics, 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 1990-04-16.
- Submission: K901171
- Applicant / Sponsor: American Medical Ceramics, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1990-04-16
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.