REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162


Device Classification Name

implant, endosseous, root-form

510(k) Number K022424
Device Name REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162
Original Applicant
NOBEL BIOCARE UAS INC
22715 savi ranch pkwy.
yorba linda, 
CA 
92887

Original Contact richard t ross
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 07/24/2002
Decision Date 09/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No