Clearance Summary
AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) received FDA 510(k) clearance under submission number K931204, sponsored by Den-Tal-Ez Mfg Co., 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 1993-07-08.
- Submission: K931204
- Applicant / Sponsor: Den-Tal-Ez Mfg Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 1993-07-08
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.