SPLINT IT

Splint, Endodontic Stabilizing

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Splint It.

Pre-market Notification Details

Device IDK972985
510k NumberK972985
Device Name:SPLINT IT
ClassificationSplint, Endodontic Stabilizing
Applicant JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
ContactMurray G Gamberg
CorrespondentMurray G Gamberg
JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford,  CT  06492 -0724
Product CodeELS  
CFR Regulation Number872.3890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-11
Decision Date1997-09-24

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