The following data is part of a premarket notification filed by Dentlight Inc. with the FDA for Dentlight Oral Exam Light Kit.
| Device ID | K101140 |
| 510k Number | K101140 |
| Device Name: | DENTLIGHT ORAL EXAM LIGHT KIT |
| Classification | Diagnostic Light, Soft Tissue Detector |
| Applicant | DENTLIGHT INC. 1411 E. CAMPBELL RD SUITE 500 Richardson, TX 75081 |
| Contact | Richard Liu |
| Correspondent | Richard Liu DENTLIGHT INC. 1411 E. CAMPBELL RD SUITE 500 Richardson, TX 75081 |
| Product Code | NXV |
| CFR Regulation Number | 872.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860179001075 | K101140 | 000 |