Approval for adding the use of biphasic calcium phosphate (haij3-tcp) bone graft materials with straumann emdogain, adding the use of collagen and other graft materials with straumann emdogain and changing the name of a contract manufacturer, in name only, from sverige, scan ab to hkscan sweden ab. The device, as modified, will be marketed under the trade name straumann emdogain and is indicated for use as an adjunct to periodontal surgery as a topical application onto exposed root surfaces. Emdogain is indicated for the treatment of the following conditions:1) intrabony defects due to moderate or severe periodontitis;2) mandibular degree ii furcations with minimal interproximal bone loss; 3) gingival recession defects in conjunction with surgical coverage procedures such asthe coronally advanced flap technique; and4) emdogain is also indicated for use in a minimally invasive surgical technique in esthetic zones to optimize tissue height for intrabony defects only. In cases of wide defects or where soft tissue support is desired, straumann emdogain can be used in conjunction with a bone graft material. For further information on the use of emdogain with bone graft materials, please refer to, for straumann emdogain in conjunction with bone graft material in wide defects in the clinical procedure section of the draft instructions.
| Device | STRAUMANN EMDOGAIN |
| Classification Name | Biologic Material, Dental |
| Generic Name | Biologic Material, Dental |
| Applicant | THE STRAUMANN COMPANY |
| Date Received | 2015-03-02 |
| Decision Date | 2015-08-26 |
| PMA | P930021 |
| Supplement | S014 |
| Product Code | NQA |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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