Recall Z-0292-2019— CMP Industries, Llc
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: 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. 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
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
Reason for recall
Foreign material in product
Data sourced from openFDA. This site is unofficial and independent of the FDA.