Approval for the addition of the following indication for use: "endogain gel is indicated for use in coronally positioned flap procedures for the treatment of gingival recession defects". The device, with this additional indication for use, will be marketed under the trade name endogain gel.
| Device | EMDOGAIN GEL |
| Classification Name | Biologic Material, Dental |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY |
| Date Received | 2002-09-13 |
| Decision Date | 2003-12-02 |
| PMA | P930021 |
| Supplement | S008 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | THE STRAUMANN COMPANY 60 Minuteman Road andover, MA 01810 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930021 | | Original Filing |
| S030 |
2023-01-04 |
30-day Notice |
| 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