The following data is part of a premarket notification filed by Pro Dental Services Llc. with the FDA for Ajax Dental Unit.
| Device ID | K132245 |
| 510k Number | K132245 |
| Device Name: | AJAX DENTAL UNIT |
| Classification | Unit, Operative Dental |
| Applicant | PRO DENTAL SERVICES LLC. 1121 PLAYER WAY Herndon, VA 20170 |
| Contact | John Neacsu |
| Correspondent | John Neacsu PRO DENTAL SERVICES LLC. 1121 PLAYER WAY Herndon, VA 20170 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971608310072 | K132245 | 000 |
| 06971608310065 | K132245 | 000 |
| 06971608310058 | K132245 | 000 |
| 06971608310041 | K132245 | 000 |
| 06971608310034 | K132245 | 000 |
| 06971608310027 | K132245 | 000 |
| 06971608310010 | K132245 | 000 |
| 06971608310003 | K132245 | 000 |