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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Endodontic Stabilizing
510(k) Number K834363
Device Name ENDIX RADICULAR BIOCERAMIC PIN
Applicant
C.B.S. Biotechnics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
C.B.S. Biotechnics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3890
Classification Product Code
ELS  
Date Received10/27/1983
Decision Date 02/27/1984
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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