INPLANT ORTHODONTIC ANCHOR SYSTEM


information about

Device Classification Name

implant, endosseous, root-form

510(k) Number K000643
Device Name INPLANT ORTHODONTIC ANCHOR SYSTEM
Original Applicant
NOBEL BIOCARE UAS INC
22725 savi ranch pkwy.
yorba linda, 
CA 
92887

Original Contact jeff hausheer
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 02/25/2000
Decision Date 09/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No