International safety notice
This product is a two-paste type resin cement for dental bonding, and the cement paste comes with a discharge port adapter. It is shipped filled in a cartridge. We are conducting a voluntary recall of this lot because it was discovered that the cartridge was not equipped with a discharge port adapter.
Japan / PMDA Recalls · JPN · Jun 27, 2024
Key facts
| Title | This product is a two-paste type resin cement for dental bonding, and the cement paste comes with a discharge port adapter. It is shipped filled in a cartridge. We are conducting a voluntary recall of this lot because it was discovered that the cartridge was not equipped with a discharge port adapter. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Resin cement for dental bonding Sales name: Esthesem II |
| Manufacturer | Tokuyama Dental Co., Ltd. |
| Models | 0640Y3, H22030 |
| Date | Jun 27, 2024 |
| 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