Approval for the change made to an original “visual inspection” room e166. The room was remodeled by means of taking down dividing walls and extended to incorporate existing e143 “labeling” space to form one large “labeling” room. Both rooms are considered to be “clean rooms”.
| Device | Straumann Emdogain |
| Classification Name | Biologic Material, Dental |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY |
| Date Received | 2018-04-13 |
| Decision Date | 2018-08-14 |
| PMA | P930021 |
| Supplement | S019 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | 135 Review Track For 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