K073483 is an FDA 510(k) clearance for the SAPPHIRE O/E ORAL EXAMINATION SYSTEM. This device is classified as a Diagnostic Light, Soft Tissue Detector (Class II - Special Controls, product code NXV).
Submitted by Den-Mat Holdings, LLC (Santa Maria, US). The FDA issued a Cleared decision on April 3, 2008, 114 days after receiving the submission on December 11, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6350. To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities.
| 510(k) Number | K073483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2007 |
| Decision Date | April 03, 2008 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | NXV - Diagnostic Light, Soft Tissue Detector |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6350 |
| Definition | To Be Used As An Aid In The Detection Or Visualization Of Abnormalities Of Intraoral Soft Tissue. An Adjunct To Traditional Intraoral Examination By Incandescent Light To Enhance The Visualization Of Oral Mucosal Abnormalities |