The following data is part of a premarket notification filed by Tulsa Dental Products, Ltd. with the FDA for Thermafil Endodontic Obturator.
| Device ID | K881139 |
| 510k Number | K881139 |
| Device Name: | THERMAFIL ENDODONTIC OBTURATOR |
| Classification | Gutta-percha |
| Applicant | TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Contact | Johnson, Dds |
| Correspondent | Johnson, Dds TULSA DENTAL PRODUCTS, LTD. 5001 EAST 68TH ST. Tulsa, OK 74136 |
| Product Code | EKM |
| CFR Regulation Number | 872.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-17 |
| Decision Date | 1988-04-07 |