W&H 898 TOP LIGHT HIGHSPEED

Handpiece, Air-powered, Dental

A-DEC, INC.

The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for W&h 898 Top Light Highspeed.

Pre-market Notification Details

Device IDK944710
510k NumberK944710
Device Name:W&H 898 TOP LIGHT HIGHSPEED
ClassificationHandpiece, Air-powered, 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 CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-23
Decision Date1995-06-02

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