The following data is part of a premarket notification filed by Schick Technologies, Inc. with the FDA for Modification To Computed Oral Radiology System.
| Device ID | K093453 |
| 510k Number | K093453 |
| Device Name: | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
| Classification | Unit, X-ray, Intraoral |
| Applicant | SCHICK TECHNOLOGIES, INC. 30-30 47TH AVE. Long Island City, NY 11101 |
| Contact | Howard Fidel |
| Correspondent | Howard Fidel SCHICK TECHNOLOGIES, INC. 30-30 47TH AVE. Long Island City, NY 11101 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-05 |
| Decision Date | 2009-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D764B24330411 | K093453 | 000 |
| D7641000054101 | K093453 | 000 |
| D7641000054111 | K093453 | 000 |
| D7641000055731 | K093453 | 000 |
| D76464046491 | K093453 | 000 |
| D76464285721 | K093453 | 000 |
| D76464835771 | K093453 | 000 |
| D764B11090001 | K093453 | 000 |
| D764B11090011 | K093453 | 000 |
| D764B11180001 | K093453 | 000 |
| D764B11180011 | K093453 | 000 |
| D764B12090021 | K093453 | 000 |
| D764B12180021 | K093453 | 000 |
| D764B13090011 | K093453 | 000 |
| D764B24310421 | K093453 | 000 |
| D764B24310431 | K093453 | 000 |
| D764B24320421 | K093453 | 000 |
| D764B24320431 | K093453 | 000 |
| D7641000053911 | K093453 | 000 |