K123169 is an FDA 510(k) clearance for the ORALID. This device is classified as a Diagnostic Light, Soft Tissue Detector (Class II - Special Controls, product code NXV).
Submitted by Forward Science, LLC (Sugar Land, US). The FDA issued a Cleared decision on March 13, 2013, 155 days after receiving the submission on October 9, 2012.
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 | K123169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2012 |
| Decision Date | March 13, 2013 |
| Days to Decision | 155 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 |