510(k) K033020 ยท EBI Resin, Denture, Relining, Repairing, Rebasing
IMPAK ACRYLIC REPAIR RESIN LIQUID
| Applicant | Cmp Industries, LLC, Albany NY, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Sep 26, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.