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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K954512
Device Name RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
Applicant
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Applicant Contact LYNN CUPERUS
Correspondent
Lifecore Biomedical, Inc.
3515 Lyman Blvd.
Chaska,  MN  55318
Correspondent Contact LYNN CUPERUS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/28/1995
Decision Date 02/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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