Company ยท US
Cmp Industries, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2017. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 2017 | K170423 | DentureID Microchip Cmp Industries, LLC | PYQ |
| Oct 2, 2017 | K170375 | Nobilplast Denture Resin Cmp Industries, LLC | EBI |
| Feb 20, 2008 | K072851 | POLYSTAR 79 DENTURE BASE RESIN Cmp Industries, LLC | EBI |
| Oct 19, 2007 | K072402 | FLEX-STAR V Cmp Industries, LLC | EBI |
| Dec 19, 2003 | K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID Cmp Industries, LLC | EBI |
| Sep 5, 1995 | K953594 | VULCAN Cmp Industries, LLC | EJH |
| Oct 4, 1990 | K902972 | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) Cmp Industries, LLC | EBI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2018 | CMP Industries, Llc Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1
REF: 3748GB.
Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards Terminated |
EBI | None listed |
| Sep 12, 2018 | CMP Industries, Llc 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 Terminated |
EBI | None listed |
| Jun 29, 2016 | CMP Industries, Llc IMPAK Liquid Acrylic Resin sold under the following labels:
1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314
2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (32 Terminated |
EBI | K033020 |
| Apr 28, 2016 | CMP Industries, Llc IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface Terminated |
EBI | K033020 |
| Apr 28, 2016 | CMP Industries, Llc 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 ACR Terminated |
EBI | K033020 |
| Mar 9, 2016 | CMP Industries, Llc IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748.
Indicated for relining a denture surface for repairing Terminated |
EBI | K033020 |