Clearance Summary
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) received FDA 510(k) clearance under submission number K051573, sponsored by Dr. Howard Martin, P.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2006-06-26.
- Submission: K051573
- Applicant / Sponsor: Dr. Howard Martin, P.A.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 2006-06-26
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.