The following data is part of a premarket notification filed by Curve Dental, Inc. with the FDA for Curve Image.
| Device ID | K110139 |
| 510k Number | K110139 |
| Device Name: | CURVE IMAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | CURVE DENTAL, INC. 611 WEST 5TH STREET, THIRD FLOOR Austin, TX 78701 |
| Contact | Caroline Tontini |
| Correspondent | Caroline Tontini CURVE DENTAL, INC. 611 WEST 5TH STREET, THIRD FLOOR Austin, TX 78701 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-18 |
| Decision Date | 2011-04-21 |
| Summary: | summary |