NUMBER 21 R/R SYSTEM

Agent, Tooth Bonding, Resin

PENTRON CORP.

The following data is part of a premarket notification filed by Pentron Corp. with the FDA for Number 21 R/r System.

Pre-market Notification Details

Device IDK841457
510k NumberK841457
Device Name:NUMBER 21 R/R SYSTEM
ClassificationAgent, Tooth Bonding, Resin
Applicant PENTRON CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-09
Decision Date1984-05-22

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