K881139 is an FDA 510(k) clearance for the THERMAFIL ENDODONTIC OBTURATOR. This device is classified as a Gutta-percha (Class I - General Controls, product code EKM).
Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on April 7, 1988, 21 days after receiving the submission on March 17, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.
| 510(k) Number | K881139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1988 |
| Decision Date | April 07, 1988 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKM — Gutta-percha |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3850 |