Clearance Summary
DEN TEMP received FDA 510(k) clearance under submission number K821581, sponsored by Majestic Drug 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 1982-06-14.
- Submission: K821581
- Applicant / Sponsor: Majestic Drug Co., Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3275
- Decision date: 1982-06-14
Classification & Regulation
This clearance is catalogued under FDA product code EMB and 21 CFR 872.3275, within the Dental review panel as a Class I device.