Clearance Summary
CRACK DETECTOR, DEN-MAT received FDA 510(k) clearance under submission number K770492, sponsored by Dey-Mat, 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 1977-03-21.
- Submission: K770492
- Applicant / Sponsor: Dey-Mat, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6140
- Decision date: 1977-03-21
Classification & Regulation
This clearance is catalogued under FDA product code EFH and 21 CFR 872.6140, within the Dental review panel as a Class I device.