ENDO ANALYZER, MODEL 8005

Tester, Pulp

SYBRON DENTAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Endo Analyzer, Model 8005.

Pre-market Notification Details

Device IDK973439
510k NumberK973439
Device Name:ENDO ANALYZER, MODEL 8005
ClassificationTester, Pulp
Applicant SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
ContactColleen Boswell
CorrespondentColleen Boswell
SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange,  CA  92667
Product CodeEAT  
CFR Regulation Number872.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-10
Decision Date1997-12-08
Summary:summary

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