EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC


Device Classification Name

bone grafting material, human source

510(k) Number K103699
Device Name EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact shing jen tai, phd
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact shing jen tai, phd
Regulation Number 872.3930
Classification Product Code
NUN  
Date Received 12/20/2010
Decision Date 08/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No