Device 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.
Z-2097-2016
Product summary
- Event
- Event 74061
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 units Total
- Official record key
device-enforcement:Z-2097-2016
Official wording
Reason: Possible presence of foreign material (rust).
Code information: Lot Number: 79943 Expiration Date: March 2021
Distribution pattern: Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
Derived failure modes
-
Foreign material or chemical contamination
foreign material