The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0293-2019·Announced 2018-11-07

CMP Industries Recalls Dental Acrylic Resin Due to Foreign Material

CMP Industries is recalling 40 units of Technoflux IMPAK dental acrylic resin because foreign material was found in the product.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is the presence of foreign material. No specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity recall involving a potential but unreported risk.

Plain-English summary

CMP Industries, LLC is recalling 40 units of Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 (REF: 3748GB). This product is an elastic acrylic resin liquid used for dental splints and dental nightguards. The recall is being conducted because foreign material was found in the product.

The affected units are from Lot Number 85827. The product was distributed worldwide, including nationwide in the United States in the states of California, Florida, Illinois, Michigan, New York, Oklahoma, Oregon, Pennsylvania, Texas, and Washington, as well as in Canada and Spain.

Consumers who have this product should stop using it and contact CMP Industries, LLC for further instructions or a refund.

The recalled product

Product
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Manufacturer
CMP Industries, Llc
Category
Medical Device — Dental Materials
Hazard
Affected units
40

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 85827

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by CMP Industries, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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