CA AND ST

Handpiece, Air-powered, Dental

DABI-ATLANTE AMERICA CORP.

The following data is part of a premarket notification filed by Dabi-atlante America Corp. with the FDA for Ca And St.

Pre-market Notification Details

Device IDK926155
510k NumberK926155
Device Name:CA AND ST
ClassificationHandpiece, Air-powered, Dental
Applicant DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa,  FL  33634
ContactUbiraci R Fernandes
CorrespondentUbiraci R Fernandes
DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa,  FL  33634
Product CodeEFB  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-07
Decision Date1994-03-04

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