K243290 is an FDA 510(k) clearance for the BTL-785MJ. This device is classified as a Stimulator, Muscle, Powered, Dental (Class II - Special Controls, product code NUW).
Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 9, 2025, 203 days after receiving the submission on October 18, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 890.5850. Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow..
| 510(k) Number | K243290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2024 |
| Decision Date | May 09, 2025 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NUW — Stimulator, Muscle, Powered, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |
| Definition | Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow. |