IMPAK ACRYLIC REPAIR RESIN LIQUID
FDA 510(k) clearance K033020 · decided 2003-12-19
Clearance details
- K-number
- K033020
- Device name
- IMPAK ACRYLIC REPAIR RESIN LIQUID
- Applicant
- Cmp Industries, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-09-26
- Decision date
- 2003-12-19
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Albany, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELAST recall (Z-2089-2016) | CMP Industries, Llc | 2016-06-29 |
| IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Num recall (Z-1089-2016) | CMP Industries, Llc | 2016-03-09 |