Home › edelweiss dentistry products gmbh › edelweiss OCCLUSION SET 47-37 S low
edelweiss OCCLUSION SET 47-37 S low
edelweiss dentistry products gmbh · Model 13185 · UDI-DI 09120046322032
10
510(k) clearances
962
Adverse events (1 deaths)
71
Recalls
206
Facilities
Description
SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 47 S, 1x edelweiss OCCLUSION 46 S, 1x edelweiss OCCLUSION 45 S, 1x edelweiss OCCLUSION 44 S, 1x edelweiss OCCLUSION 34 S, 1x edelweiss OCCLUSION 35 S, 1x edelweiss OCCLUSION 36 S, 1x edelweiss OCCLUSION 37 S)
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.