Updating the environmental monitoring program; relocating the doors to a refrigerator and freezer (moved from one wall to another); and introducing a cutting tool and changed tolerance for seal strength test strips
| Device | Staumann Emdogain |
| Classification Name | Biologic Material, Dental |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY |
| Date Received | 2019-08-09 |
| Decision Date | 2019-09-03 |
| PMA | P930021 |
| Supplement | S025 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| 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