Recall Z-2097-2016— CMP Industries, Llc

Name: FDA recall Z-2097-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-28

Class II · Terminated

Class II FDA medical device recall by CMP Industries, Llc, initiated 2016-04-28, terminated 2018-05-25. It names one FDA 510(k) clearance: K033020. Product: IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.. Reason: Possible presence of foreign material (rust)..

Recalling firm: CMP Industries, Llc
Classification: Class II
Status: Terminated
Initiated: 2016-04-28
Terminated: 2018-05-25
Firm location: Albany, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K033020 — IMPAK ACRYLIC REPAIR RESIN LIQUIDCmp Industries, LLC·cleared 2003-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450; Indicated for relining a denture surface.

Reason for recall

Possible presence of foreign material (rust).

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