Cmp Industries, LLC
Medical device manufacturer in Albany, NY.
7510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K170423 | DentureID MicrochipPYQ · Traditional | 10/25/2017SE |
| K170375 | Nobilplast Denture ResinEBI · Traditional | 10/02/2017SE |
| K072851 | Polystar 79 Denture Base ResinEBI · Traditional | 02/20/2008SE |
| K072402 | Flex-Star VEBI · Traditional | 10/19/2007SE |
| K033020 | Impak Acrylic Repair Resin LiquidEBI · Traditional | 12/19/2003SE |
| K953594 | VulcanEJH · Traditional | 09/05/1995SE |
| K902972 | Flexor (Denture Acrylic Reline Material)EBI · Traditional | 10/04/1990SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0293-2019 Class II | Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF:…Foreign material in product | 09/12/2018Terminated |
| Z-0292-2019 Class II | IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306.…Foreign material in product | 09/12/2018Terminated |
| Z-2098-2016 Class II | IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder…Possible presence of foreign material (rust). | 04/28/2016Terminated |
| Z-2097-2016 Class II | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC…Possible presence of foreign material (rust). | 04/28/2016Terminated |
| Z-2089-2016 Class II | IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED…Possible presence of foreign material (rust). | 03/02/2016Terminated |
| Z-1089-2016 Class II | IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part…During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted… | 11/18/2013Terminated |