AJAX DENTAL UNIT

Unit, Operative Dental

PRO DENTAL SERVICES LLC.

The following data is part of a premarket notification filed by Pro Dental Services Llc. with the FDA for Ajax Dental Unit.

Pre-market Notification Details

Device IDK132245
510k NumberK132245
Device Name:AJAX DENTAL UNIT
ClassificationUnit, Operative Dental
Applicant PRO DENTAL SERVICES LLC. 1121 PLAYER WAY Herndon,  VA  20170
ContactJohn Neacsu
CorrespondentJohn Neacsu
PRO DENTAL SERVICES LLC. 1121 PLAYER WAY Herndon,  VA  20170
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-18
Decision Date2014-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971608310072 K132245 000
06971608310065 K132245 000
06971608310058 K132245 000
06971608310041 K132245 000
06971608310034 K132245 000
06971608310027 K132245 000
06971608310010 K132245 000
06971608310003 K132245 000

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