Approval for packaging changes for emdogain(r). The following packaging changes are now approved: 1) a change in the size of the glass vial in which the emdogain powder is supplied from 10 ml to 6 ml; 2) a change from a freezer type rubber stopper to an injection type rubber stopper for the vehicle solution vials and 3) availability of 10 mg of the product in addition to the originally approved 30 mg of the product.
| Device | EMDOGAIN |
| Classification Name | Biologic Material, Dental |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY |
| Date Received | 1999-05-20 |
| Decision Date | 1999-08-24 |
| PMA | P930021 |
| Supplement | S003 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| 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