The following data is part of a premarket notification filed by Den-mat Holdings, Llc with the FDA for Sapphire O/e Oral Examination System.
| Device ID | K073483 |
| 510k Number | K073483 |
| Device Name: | SAPPHIRE O/E ORAL EXAMINATION SYSTEM |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Contact | Alan Matthews |
| Correspondent | Alan Matthews DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. Santa Maria, CA 93455 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-11 |
| Decision Date | 2008-04-03 |