NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX


Device Classification Name

implant, endosseous, root-form

510(k) Number K072363
Device Name NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
Applicant
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact diana taylor
Correspondent
BIOMET 3I, INC.
4555 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact diana taylor
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 08/23/2007
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No