GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX

Articulators

SDS DENTAL, INC.

The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Gnatus Articulator 4.300/4.300gp 8.600 & Ortoflex.

Pre-market Notification Details

Device IDK863009
510k NumberK863009
Device Name:GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX
ClassificationArticulators
Applicant SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington,  DC  20016
ContactCesar Coral
CorrespondentCesar Coral
SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington,  DC  20016
Product CodeEJP  
CFR Regulation Number872.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-08
Decision Date1986-09-25

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