REAMER TYPE K ENDODONTIC

Reamer, Pulp Canal, Endodontic

UNITED DENTAL MFG., INC.

The following data is part of a premarket notification filed by United Dental Mfg., Inc. with the FDA for Reamer Type K Endodontic.

Pre-market Notification Details

Device IDK823686
510k NumberK823686
Device Name:REAMER TYPE K ENDODONTIC
ClassificationReamer, Pulp Canal, Endodontic
Applicant UNITED DENTAL MFG., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEKP  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-07
Decision Date1982-12-28

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