A-DEC RADIUS 2122/2132

Unit, Operative Dental

A-DEC, INC.

The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Radius 2122/2132.

Pre-market Notification Details

Device IDK940893
510k NumberK940893
Device Name:A-DEC RADIUS 2122/2132
ClassificationUnit, Operative Dental
Applicant A-DEC, INC. 2601 CRESTVIEW DR. Newberg,  OR  97132 -9257
ContactPatrick Ridenour
CorrespondentPatrick Ridenour
A-DEC, INC. 2601 CRESTVIEW DR. Newberg,  OR  97132 -9257
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-25
Decision Date1994-07-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.