ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX


Device Classification Name

implant, endosseous, root-form

510(k) Number K080074
Device Name ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
Applicant
ACE SURGICAL SUPPLY CO., INC.
1034 pearl st.
brockton, 
MA 
02301

Applicant Contact j. edward carchidi
Correspondent
ACE SURGICAL SUPPLY CO., INC.
1034 pearl st.
brockton, 
MA 
02301

Correspodent Contact j. edward carchidi
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 01/11/2008
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No