A-dec 300, A-dec 500

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 300, A-dec 500.

Pre-market Notification Details

Device IDK213932
510k NumberK213932
Device Name:A-dec 300, A-dec 500
ClassificationUnit, Operative Dental
Applicant A-dec, Inc. 2601 Crestview Drive Newberg,  OR  97132
ContactRaquel Peregrino De Brito
CorrespondentRaquel Peregrino De Brito
A-dec, Inc. 2601 Crestview Drive Newberg,  OR  97132
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-16
Decision Date2022-03-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10194665005320 K213932 000
10194665006730 K213932 000
10194665005399 K213932 000
10194665005405 K213932 000
10194665005412 K213932 000
10194665005429 K213932 000
10194665005436 K213932 000
10194665005856 K213932 000
10194665005863 K213932 000
10194665005870 K213932 000
10194665005894 K213932 000
10194665005900 K213932 000
10194665005917 K213932 000
10194665005986 K213932 000
10194665005993 K213932 000
10194665007300 K213932 000

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