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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K983104
Device Name NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
Applicant
Norian Corp.
10260 Bubb Rd.
Cupertino,  CA  95014 -4166
Applicant Contact KIM TOMPKINS
Correspondent
Norian Corp.
10260 Bubb Rd.
Cupertino,  CA  95014 -4166
Correspondent Contact KIM TOMPKINS
Regulation Number872.3930
Classification Product Code
LYC  
Date Received09/04/1998
Decision Date 02/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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