MINIFIX BALL MINIFIX ONE


Device Classification Name

implant, endosseous, root-form

510(k) Number K122052
Device Name MINIFIX BALL MINIFIX ONE
Applicant
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 w. prive cr.
delray beach, 
FL 
33445

Applicant Contact juan tezak
Correspondent
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
118 w. prive cr.
delray beach, 
FL 
33445

Correspodent Contact juan tezak
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 07/12/2012
Decision Date 11/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No