The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Cdr-cam.
| Device ID | K963778 |
| 510k Number | K963778 |
| Device Name: | CDR-CAM |
| Classification | Unit, Operative Dental |
| Applicant | SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island, NY 11101 |
| Contact | Enrico Renzi |
| Correspondent | Enrico Renzi SCHICK TECHNOLOGIES, INC. 31-00 47TH AVE. Long Island, NY 11101 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-20 |
| Decision Date | 1996-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D764B63061000 | K963778 | 000 |
| D764B63060111 | K963778 | 000 |
| D764B6306010R1 | K963778 | 000 |
| D764B63031000 | K963778 | 000 |
| D764B6303010R1 | K963778 | 000 |
| D764B63030001 | K963778 | 000 |