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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 K834364
Device Name CRYSTALLINE BONE SCREW ENDO-OSSEOUS
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 Number872.3640
Classification Product Code
DZE  
Date Received10/27/1983
Decision Date 03/06/1984
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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