K952218 is an FDA 510(k) clearance for the JT-3 ELECTROGNATHOGRAPH. This device is classified as a Device, Jaw Tracking, For Monitoring Jaw Positions (Class I - General Controls, product code NFS).
Submitted by Bio-Research Associates, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 21, 1995, 133 days after receiving the submission on May 11, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.2060.
| 510(k) Number | K952218 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1995 |
| Decision Date | September 21, 1995 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | NFS — Device, Jaw Tracking, For Monitoring Jaw Positions |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.2060 |