Straumann® Emdogain®

FDA Premarket Approval P930021 S029

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

DeviceStraumann® Emdogain®
Generic NameBiologic Material, Dental
ApplicantTHE STRAUMANN COMPANY60 Minuteman Roadandover, MA 01810 PMA NumberP930021 Supplement NumberS029 Date Received10/17/2022 Decision Date11/16/2022 Product Code NQA  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-17
Decision Date2022-11-16
PMAP930021
SupplementS029
Product CodeNQA 
Advisory CommitteeDental
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressTHE STRAUMANN COMPANY
60 Minuteman Road
andover, MA 01810 PMA NumberP930021 Supplement NumberS029 Date Received10/17/2022 Decision Date11/16/2022 Product Code NQA  Advisory Committee Dental Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
- Improved Settings For HPLC Identification (ID) Method For Emdogain (test Method For In-process Control And Final Release Testing)- Removal Of Redundant Acetic Acid Content Determination (release Testing)- Removal Of One Redundant Calcium Concentration Determination (in-process Control)- Removal Of Redundant Sampling Step On Emdogain Gel Bulk(in-process Control

Supplemental Filings

Supplement NumberDateSupplement Type
P930021Original Filing
S029 2022-10-17 30-day Notice
S028
S027 2021-01-29 30-day Notice
S026 2020-08-12 30-day Notice
S025 2019-08-09 30-day Notice
S024
S023 2018-11-02 135 Review Track For 30-day Notice
S022 2018-10-24 135 Review Track For 30-day Notice
S021 2018-10-22 135 Review Track For 30-day Notice
S020 2018-05-10 30-day Notice
S019 2018-04-13 135 Review Track For 30-day Notice
S018 2017-12-15 135 Review Track For 30-day Notice
S017 2016-09-09 135 Review Track For 30-day Notice
S016 2016-04-06 Normal 180 Day Track
S015 2015-06-29 30-day Notice
S014 2015-03-02 Normal 180 Day Track
S013 2012-09-19 Normal 180 Day Track No User Fee
S012 2009-01-12 Normal 180 Day Track No User Fee
S011 2008-03-27 Normal 180 Day Track
S010 2007-10-09 Real-time Process
S009 2006-04-11 Special (immediate Track)
S008 2002-09-13 Normal 180 Day Track
S007 2002-07-01 Normal 180 Day Track
S006 2002-06-17 Normal 180 Day Track
S005 2000-07-26 Normal 180 Day Track
S004 2000-03-09 Real-time Process
S003 1999-05-20 Normal 180 Day Track
S002 1999-01-26 Normal 180 Day Track
S001 1998-01-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07630031700100 P930021 013
07630031700025 P930021 013
07630031700087 P930021 013
07630031730046 P930021 020
07630031729989 P930021 020
07630031730015 P930021 020
07630031730022 P930021 020
07630031730039 P930021 020
07630031747389 P930021 024
07630031747372 P930021 024

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