The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Orthalgenat Impression Material.
| Device ID | K942666 |
| 510k Number | K942666 |
| Device Name: | ORTHALGENAT IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | Johen J Roth |
| Correspondent | Johen J Roth DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1994-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J011150520300 | K942666 | 000 |
| J011150509300 | K942666 | 000 |
| J011150501300 | K942666 | 000 |
| J011150520200 | K942666 | 000 |
| J011150509200 | K942666 | 000 |
| J011150501200 | K942666 | 000 |