PALASEAL(R)

Resin, Denture, Relining, Repairing, Rebasing

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Palaseal(r).

Pre-market Notification Details

Device IDK892452
510k NumberK892452
Device Name:PALASEAL(R)
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant KULZER, INC. 111 N. WABASH AVE. Chicago,  IL  60602
ContactBauer, Phd
CorrespondentBauer, Phd
KULZER, INC. 111 N. WABASH AVE. Chicago,  IL  60602
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-10
Decision Date1989-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014647106140 K892452 000
J014647080610 K892452 000
J014647080630 K892452 000

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