DENTAL ROOT ELEVATOR

Denture Preformed (partially Prefabricated Denture)

ZINNANTI SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Dental Root Elevator.

Pre-market Notification Details

Device IDK892255
510k NumberK892255
Device Name:DENTAL ROOT ELEVATOR
ClassificationDenture Preformed (partially Prefabricated Denture)
Applicant ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
ContactAnthony Zinnanti
CorrespondentAnthony Zinnanti
ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth,  CA  91311
Product CodeEKO  
CFR Regulation Number872.3600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-04
Decision Date1989-05-01

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