The following data is part of a premarket notification filed by Dr. Howard Martin, P.a. with the FDA for Tgp (gutta Percha Containing Tetracycline Or Doxycycline).
| Device ID | K051573 |
| 510k Number | K051573 |
| Device Name: | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) |
| Classification | Gutta-percha |
| Applicant | DR. HOWARD MARTIN, P.A. 4327 REELS MILL RD. Frederick, MD 21704 |
| Contact | Kyle H Sibinovic |
| Correspondent | Kyle H Sibinovic DR. HOWARD MARTIN, P.A. 4327 REELS MILL RD. Frederick, MD 21704 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-06-14 |
| Decision Date | 2006-06-26 |