Recall Z-0293-2019— CMP Industries, Llc

Name: FDA recall Z-0293-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-12

Class II · Terminated

Class II FDA medical device recall by CMP Industries, Llc, initiated 2018-09-12, terminated 2020-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Foreign material in product.

Recalling firm: CMP Industries, Llc
Classification: Class II
Status: Terminated
Initiated: 2018-09-12
Terminated: 2020-05-19
Firm location: Albany, NY, United States

Product description

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

Reason for recall

Foreign material in product

Data sourced from openFDA. This site is unofficial and independent of the FDA.