The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Dental Tray, Sterile, Disposable.
| Device ID | K974238 |
| 510k Number | K974238 |
| Device Name: | DENTAL TRAY, STERILE, DISPOSABLE |
| Classification | Unit, Operative Dental |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. Salisbury, MD 21801 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-02-04 |