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edelweiss OCCLUSION SET 17-27 M up
edelweiss dentistry products gmbh · Model 13175 · UDI-DI 09120046322018
10
510(k) clearances
961
Adverse events (1 deaths)
71
Recalls
207
Facilities
Description
SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 17 M, 1x edelweiss OCCLUSION 16 M, 1x edelweiss OCCLUSION 15 M, 1x edelweiss OCCLUSION 14 M, 1x edelweiss OCCLUSION 24 M, 1x edelweiss OCCLUSION 25 M, 1x edelweiss OCCLUSION 26 M, 1x edelweiss OCCLUSION 27 M)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2026-07-09 | Henry Schein Inc. | Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2024-08-02 | Ultradent Products, Inc. | Due to a manufacturing issue, red particulates present in the expressed composite. |
| 2020-08-31 | Ultradent Products, Inc. | Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. |
| 2019-07-09 | Voco GmbH | The metal cannula are potentially too loose and may become loose when applying the filing material. |
| 2019-01-31 | RHONDIUM LIMITED | The product was mislabeled with an incorrect expiration date. |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
| 2017-08-03 | Ivoclar Vivadent, Inc. | Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing |
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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.