SET CANAL SEALER PASTE

Gutta-percha

ENDO TECHNIC CORP.

The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Set Canal Sealer Paste.

Pre-market Notification Details

Device IDK862129
510k NumberK862129
Device Name:SET CANAL SEALER PASTE
ClassificationGutta-percha
Applicant ENDO TECHNIC CORP. ONE APPLE HILL, STE 316 Natick,  MA  01760
ContactStewart Lustgarten
CorrespondentStewart Lustgarten
ENDO TECHNIC CORP. ONE APPLE HILL, STE 316 Natick,  MA  01760
Product CodeEKM  
CFR Regulation Number872.3850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-04
Decision Date1986-07-22

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