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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
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