Z-0292-2019Class II

IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak...

Name: Z-0292-2019 IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak...
Creator: CMP Industries, Llc
Published: 2018-09-12
License: https://open.fda.gov/license/

Cmp Industries, LLC / initiated 2018-09-12 / Terminated / root cause: manufacturing process

FDA source

CMP Industries, Llc began a recall of 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... on 2018-09-12. FDA classified it as Class II and gives the reason as "Foreign material in product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0292-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Posted: 2018-10-30
Terminated: 2020-05-19
Recalling firm: Cmp Industries, LLC
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
Product code: EBI Resin, Denture, Relining, Repairing, Rebasing
Reason for recall: Foreign material in product
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Nobilium, A Division of CMP Industries LLC notified customer by phone and certified mail on 9/12/18 advising users of the problem and to return product.. Distributors requested to notify the user level (dental laboratory who processed this material. Questions, call 518-434-3147, extension 144, M-F 8-4:30pm (Eastern).
Quantity in commerce: 400 units
Distribution: Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.
Product codes and lots: Lot Number: 85623 , 85827

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0292-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0292-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30
Z-0293-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-30

Product code EBI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)