RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM

Implant, Endosseous, Root-form

LIFECORE BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Lifecore Biomedical, Inc. with the FDA for Restore Hex Cylinder Endosseous System.

Pre-market Notification Details

Device IDK931468
510k NumberK931468
Device Name:RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska,  MN  55318
ContactLynn Cuperus
CorrespondentLynn Cuperus
LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska,  MN  55318
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-24
Decision Date1994-07-12

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