K974238 is an FDA 510(k) clearance for the DENTAL TRAY, STERILE, DISPOSABLE. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on February 4, 1998, 84 days after receiving the submission on November 12, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K974238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1997 |
| Decision Date | February 04, 1998 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |