The following data is part of a premarket notification filed by Anatomage, Inc with the FDA for Invivodental.
| Device ID | K070803 |
| 510k Number | K070803 |
| Device Name: | INVIVODENTAL |
| Classification | System, Image Processing, Radiological |
| Applicant | ANATOMAGE, INC 111N. MARKET ST, STE 930 San Jose, CA 95113 |
| Contact | Robert J Chin |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-23 |
| Decision Date | 2007-04-06 |
| Summary: | summary |