FILLOCK REAMER

Drill, Dental, Intraoral

IVOCLAR NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Fillock Reamer.

Pre-market Notification Details

Device IDK901097
510k NumberK901097
Device Name:FILLOCK REAMER
ClassificationDrill, Dental, Intraoral
Applicant IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
ContactL Severance,dds
CorrespondentL Severance,dds
IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst,  NY  14228
Product CodeDZA  
CFR Regulation Number872.4130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-07
Decision Date1990-04-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.