K101140 is an FDA 510(k) clearance for the DENTLIGHT ORAL EXAM LIGHT KIT. This device is classified as a Diagnostic Light, Soft Tissue Detector (Class II - Special Controls, product code NXV).
Submitted by Dentlight, Inc. (Richardson, US). The FDA issued a Cleared decision on July 15, 2010, 84 days after receiving the submission on April 22, 2010.
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 | K101140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2010 |
| Decision Date | July 15, 2010 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| 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 |