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[Recalled] IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards — Foreign material in product | FDA 201
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards |
|---|---|
| Brand / manufacturer | CMP Industries, Llc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0292-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 12 September 2018 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Foreign material in product
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from CMP Industries, Llc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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