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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 Namebone grafting material, for dental bone repair
Generic Namebone grafting material, for dental bone repair
Regulation Number872.3930
lindigstrasse 4
kleinostheim D-638-6380
PMA NumberP800035
Date Received06/12/1980
Decision Date03/24/1981
Reclassified Date 05/31/2005
Product Code
LPK[ Registered Establishments with LPK ]
Notice Date 04/13/1981
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S007 S008 S010 S011