The following data is part of a premarket notification filed by Video Dental Concepts, Inc. with the FDA for Oracam.
| Device ID | K020957 |
| 510k Number | K020957 |
| Device Name: | ORACAM |
| Classification | Unit, Operative Dental |
| Applicant | VIDEO DENTAL CONCEPTS, INC. 110 EAST GRANADA BLVD. SUITE 208; P.O. BOX 36 Ormond Beach, FL 32175 -0036 |
| Contact | Claude D Berthoin |
| Correspondent | Claude D Berthoin VIDEO DENTAL CONCEPTS, INC. 110 EAST GRANADA BLVD. SUITE 208; P.O. BOX 36 Ormond Beach, FL 32175 -0036 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-06-13 |