2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN

Resin, Denture, Relining, Repairing, Rebasing

ASTRON DENTAL CORP.

The following data is part of a premarket notification filed by Astron Dental Corp. with the FDA for 2nd Modified Vinylac Press Pack Denture Resin.

Pre-market Notification Details

Device IDK874025
510k NumberK874025
Device Name:2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling,  IL  60090
ContactR. E Muller
CorrespondentR. E Muller
ASTRON DENTAL CORP. 280 HOLDBROOK DR. Wheeling,  IL  60090
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-02
Decision Date1987-12-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D810PUFMCSEK11 K874025 000
D810PUFCLREK11 K874025 000
D810PUF99SEK11 K874025 000
D810PUF99LK11 K874025 000
D810PUF99EK11 K874025 000
D810PLTELSEK11 K874025 000
D810PLTELEK11 K874025 000
D810PLTDFPFSEK11 K874025 000
D810PLTDFPFEK11 K874025 000
D810PLTCLRSEK11 K874025 000
D810PLTCLREK11 K874025 000
D810PLT99SEK11 K874025 000
D810PUFCLRLK11 K874025 000
D810PUFCLRSEK11 K874025 000
D810PUFMCLK1 K874025 000
D810PUFMCEK11 K874025 000
D810PUFMCDARKSEK11 K874025 000
D810PUFMCDARKLK11 K874025 000
D810PUFMCDARKEK11 K874025 000
D810PUFELSEK11 K874025 000
D810PUFELLK11 K874025 000
D810PUFELEK11 K874025 000
D810PUFDFPFSEK11 K874025 000
D810PUFDFPFLK11 K874025 000
D810PUFDFPFEK11 K874025 000
D810PLT99EK11 K874025 000

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