DENTAL OR SURGICAL BUR

Bur, Dental

STRATUM DENTAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Stratum Dental Technologies, Inc. with the FDA for Dental Or Surgical Bur.

Pre-market Notification Details

Device IDK923883
510k NumberK923883
Device Name:DENTAL OR SURGICAL BUR
ClassificationBur, Dental
Applicant STRATUM DENTAL TECHNOLOGIES, INC. 1000 WEST BONANZA RD. Las Vegas,  NV  89106
ContactK. L Hall
CorrespondentK. L Hall
STRATUM DENTAL TECHNOLOGIES, INC. 1000 WEST BONANZA RD. Las Vegas,  NV  89106
Product CodeEJL  
CFR Regulation Number872.3240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-04
Decision Date1993-07-27

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