ASTRON 77 INJECTION 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 Astron 77 Injection Denture Resin.

Pre-market Notification Details

Device IDK833270
510k NumberK833270
Device Name:ASTRON 77 INJECTION DENTURE RESIN
ClassificationResin, Denture, Relining, Repairing, Rebasing
Applicant ASTRON DENTAL CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-21
Decision Date1984-07-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D8101180MFT11 K833270 000
D8101180LFT11 K833270 000
D8101180EC11 K833270 000

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