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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 K842163
Device Name RIDGEMATRIX 20/40 MESH, PERIOMATRIX
Applicant
ORTHOMATRIX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ORTHOMATRIX, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number872.3930
Classification Product Code
LYC  
Date Received05/30/1984
Decision Date 08/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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