PALATRAY LC RESIN IMPRESSION TRAY MATERIAL

Material, Impression Tray, Resin

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palatray Lc Resin Impression Tray Material.

Pre-market Notification Details

Device IDK902350
510k NumberK902350
Device Name:PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
ClassificationMaterial, Impression Tray, Resin
Applicant KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
ContactBarbara J Brown
CorrespondentBarbara J Brown
KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine,  CA  92718
Product CodeEBH  
CFR Regulation Number872.3670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-25
Decision Date1990-07-26

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