FDA-Device2018-11-07Class II

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

CMP Industries, Llc
Hazard

Foreign material in product

Sold states
Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.
Affected count
400 units
Manufactured in
413 N Pearl St, N/A, Albany, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0292-2019

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