REGULAR DIAMETER SINGLE STAGE (RDS) 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 Regular Diameter Single Stage (rds) Tps Dental Implant System.

Pre-market Notification Details

Device IDK991114
510k NumberK991114
Device Name:REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant LIFECORE BIOMEDICAL, INC. 3515 LYMAN BLVD. Chaska,  MN  55318
ContactCarolyn Anderson
CorrespondentCarolyn Anderson
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 Received1999-04-01
Decision Date1999-07-14
Summary:summary

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