International safety notice
This product has different color tones between white and clear (nearly transparent white), but the white product has a clear color. It was discovered that the product was shipped with a legally required label affixed to it, and we have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Oct 4, 2021
Key facts
| Title | This product has different color tones between white and clear (nearly transparent white), but the white product has a clear color. It was discovered that the product was shipped with a legally required label affixed to it, and we have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Resin cement for dental bonding Sales name: Max Sem Elite |
| Manufacturer | Kabo Dental Systems Co., Ltd. |
| Models | 8151413, 0.808.0258 |
| Date | Oct 4, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1