RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT 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 Tps Dental Implant System Sustain Tps Dental Implant System.

Pre-market Notification Details

Device IDK954819
510k NumberK954819
Device Name:RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT 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 Received1995-10-20
Decision Date1996-01-11

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