MYERSON'S PERMASOFT SOFT RELINE MATERIAL

Resin, Denture, Relining, Repairing, Rebasing

AUSTENAL, INC.

The following data is part of a premarket notification filed by Austenal, Inc. with the FDA for Myerson's Permasoft Soft Reline Material.

Pre-market Notification Details

Device IDK933468
510k NumberK933468
Device Name:MYERSON'S PERMASOFT SOFT RELINE MATERIAL
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant AUSTENAL, INC. 4101 WEST 51ST ST. Chicago,  IL  60632 -4287
ContactRonald Dudek
CorrespondentRonald Dudek
AUSTENAL, INC. 4101 WEST 51ST ST. Chicago,  IL  60632 -4287
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-16
Decision Date1994-01-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842326102002 K933468 000
D001N8150020 K933468 000
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D001N8125000 K933468 000
D001N8121000 K933468 000
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D001N8116000 K933468 000
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D001N8114000 K933468 000
D001N8111000 K933468 000
D001N8150030 K933468 000
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D001N8151010 K933468 000
00842326101999 K933468 000
00842326101982 K933468 000
00842326101975 K933468 000
00842326101968 K933468 000
00842326101951 K933468 000
D001N8160050 K933468 000
D001N8160020 K933468 000
D001N8151050 K933468 000
D001N8151030 K933468 000
D001N8151020 K933468 000
D001N8110000 K933468 000

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