The following data is part of a premarket notification filed by Sota Precision Optics, Inc. with the FDA for Claris I310d Intraoral Camera System & Accessories.
| Device ID | K061175 |
| 510k Number | K061175 |
| Device Name: | CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES |
| Classification | Unit, Operative Dental |
| Applicant | SOTA PRECISION OPTICS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour SOTA PRECISION OPTICS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-05-23 |
| Summary: | summary |