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Emdogain
Institut Straumann AG · Model 1 · UDI-DI 07630031700100
NQA
Prescription
0
510(k) clearances
10
Adverse events (1 deaths)
7
Recalls
7
Facilities
Description
Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® Emdogain 0.3 ml, 3 syringes Straumann® PrefGel® 0.6 ml and 6 blunt cannulas
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-17 | Straumann USA LLC | The possibility for this product that is intended for demonstration purposes only to be placed in patients. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
| 2018-03-23 | Straumann Manufacturing, Inc. | 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. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.