The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for O-tray Impression Trays.
| Device ID | K942668 |
| 510k Number | K942668 |
| Device Name: | O-TRAY IMPRESSION TRAYS |
| Classification | Tray, Impression, Preformed |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | John J Roth |
| Correspondent | John J Roth DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | EHY |
| CFR Regulation Number | 872.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1994-07-22 |