K900986 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 November 13, 1990, 257 days after receiving the submission on March 1, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.
| 510(k) Number | K900986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1990 |
| Decision Date | November 13, 1990 |
| Days to Decision | 257 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 |