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 |