GEM 21S (GROWTH-FACTOR ENHANCED MATRIX

Bone Grafting Material, Dental, With Biologic Component

FDA Premarket Approval P040013

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.

Pre-market Approval Supplement Details

Approval for the gem 21s (growth-factor enhanced matrix). The device is indicated to treat the following periodontally related defects: 1) intrabony periodontal defects 2) furcation periodontal defects 3) gingival recession associated with periodontal defects.

• Device: GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
• Classification Name: Bone Grafting Material, Dental, With Biologic Component
• Generic Name: Bone Grafting Material, Dental, With Biologic Component
• Applicant: Lynch Biologics LLC
• Date Received: 2004-03-12
• Decision Date: 2005-11-18
• Notice Date: 2005-11-28
• PMA: P040013
• Supplement: S
• Product Code: NPZ
• Docket Number: 05M-0474
• Advisory Committee: Dental
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Lynch Biologics LLC 5526 Joseph Street franklin, TN 37064
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P040013		Original Filing
S025	2020-11-27	Real-time Process
S024	2020-04-17	Normal 180 Day Track No User Fee
S023	2020-03-24	Normal 180 Day Track No User Fee
S022	2019-03-21	Normal 180 Day Track No User Fee
S021	2015-06-22	Normal 180 Day Track No User Fee
S020	2015-01-21	Special (immediate Track)
S019	2014-05-05	135 Review Track For 30-day Notice
S018	2012-02-29	Special (immediate Track)
S017	2011-06-24	Normal 180 Day Track No User Fee
S016	2010-12-11	Normal 180 Day Track
S015	2009-08-14	Normal 180 Day Track No User Fee
S014	2009-07-06	Normal 180 Day Track No User Fee
S013	2008-03-26	Normal 180 Day Track
S012	2007-11-23	Normal 180 Day Track No User Fee
S011	2007-05-22	135 Review Track For 30-day Notice
S010
S009	2006-12-22	Special (immediate Track)
S008	2006-10-20	30-day Notice
S007
S006	2006-08-09	30-day Notice
S005	2006-07-31	Real-time Process
S004	2006-05-31	Normal 180 Day Track No User Fee
S003	2006-04-06	Normal 180 Day Track No User Fee
S002	2006-02-27	Real-time Process
S001

NIH GUDID Devices

Device ID	PMA	Supp
00850001118002	P040013	000