DENTAL HANDPIECE AND ACCESSORY

Handpiece, Air-powered, Dental

FILMTECH, INC.

The following data is part of a premarket notification filed by Filmtech, Inc. with the FDA for Dental Handpiece And Accessory.

Pre-market Notification Details

Device IDK963664
510k NumberK963664
Device Name:DENTAL HANDPIECE AND ACCESSORY
ClassificationHandpiece, Air-powered, Dental
Applicant FILMTECH, INC. 581 MCDONALD AVE. Brooklyn,  NY  11218
ContactJacob Posner
CorrespondentJacob Posner
FILMTECH, INC. 581 MCDONALD AVE. Brooklyn,  NY  11218
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-13
Decision Date1996-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D764B13070110 K963664 000
D764B10700090 K963664 000
D764B10700171 K963664 000
D764B10700181 K963664 000
D764B11070100 K963664 000
D764B11070110 K963664 000
D764B12070100 K963664 000
D764B12070110 K963664 000
D764B12100300 K963664 000
D764B13070100 K963664 000
D764B10700080 K963664 000

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