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Straumann Emdogain
Model Emdogain · Institut Straumann AG · DI 07630031747372
NQA — Biologic Material, Dental · Class III · 21 CFR 872.3930
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (7)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2025-10-17 | Z-0582-2026 | Class II | Open, Classified | The possibility for this product that is intended for demonstration purposes only to be placed in patients. | k number procode |
| 2018-03-23 | Z-1694-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
| 2018-03-23 | Z-1695-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
| 2018-03-23 | Z-1693-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
| 2018-03-23 | Z-1697-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
| 2018-03-23 | Z-1698-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
| 2018-03-23 | Z-1696-2018 | Class II | Terminated | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. | k number procode |
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- P930021 OK30 2025-09-05 (k number procode)
- P930021 APPR 2025-06-10 (k number procode)
- P930021 OK30 2023-06-21 (k number procode)
- P930021 OK30 2023-04-18 (k number procode)
- P930021 APPR 2023-04-04 (k number procode)
- P930021 OK30 2023-02-03 (k number procode)
- P930021 OK30 2022-11-16 (k number procode)
- P930021 OK30 2021-02-22 (k number procode)
- P930021 OK30 2020-09-02 (k number procode)
- P930021 APPR 2020-05-15 (k number procode)
- P930021 OK30 2019-09-03 (k number procode)
- P930021 APPR 2019-06-21 (k number procode)
- P930021 APPR 2019-04-26 (k number procode)
- P930021 APPR 2019-04-23 (k number procode)
- P930021 APPR 2018-09-28 (k number procode)
- P930021 APPR 2018-08-14 (k number procode)
- P930021 OK30 2018-07-09 (k number procode)
- P930021 APPR 2017-03-28 (k number procode)
- P930021 APPR 2017-02-17 (k number procode)
- P930021 APPR 2015-08-26 (k number procode)
Manufacturer compliance record — Institut Straumann AG
- VAI 2018-08-30 Straumann Manufacturing, Inc · 2 citations
- VAI 2017-12-07 Jjgc Industria E Comercio De Materials Dentarios Sa · 4 citations
- VAI 2017-07-21 Straumann USA LLC · 6 citations
- OAI 2016-06-02 ANTHOGYR SAS · 5 citations
- NAI 2014-11-13 Straumann USA LLC · 0 citations
- NAI 2014-11-13 Straumann USA LLC · 0 citations
- NAI 2014-09-03 Biora AB · 0 citations