SYNTHOGRAFT(TM) LARGE GRANULAR (LG)

FDA Premarket Approval P800035 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceSYNTHOGRAFT(TM) LARGE GRANULAR (LG)
Generic NameImplant, Endosseous, Root-form
ApplicantCURASAN AG
Date Received1982-06-15
Decision Date1982-08-09
PMAP800035
SupplementS005
Product CodeDZE 
Advisory CommitteeDental
Expedited ReviewNo
Combination Product No
Applicant Address CURASAN AG lindigstrasse 4 kleinostheim D-638-6380

Supplemental Filings

Supplement NumberDateSupplement Type
P800035Original Filing
S011 2002-04-05 Normal 180 Day Track
S010 2001-06-25 Normal 180 Day Track
S009
S008 1983-10-11
S007 1983-09-13
S006
S005 1982-06-15
S004 1982-12-20
S003 1982-10-22
S002 1982-06-30
S001 1981-12-14

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