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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Nameimplant, endosseous, root-form
Generic Nameimplant, endosseous, root-form
Regulation Number872.3640
2500 faber place
palo alto, CA 94303
PMA NumberP860012
Date Received04/02/1986
Decision Date10/28/1988
Reclassified Date 05/31/2005
Product Code
DZE[ Registered Establishments with DZE ]
Docket Number 89M-0003
Notice Date 02/15/1989
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005