K223182 is an FDA 510(k) clearance for the Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy. This device is classified as a Dental Amalgam (Class II - Special Controls, product code OIV).
Submitted by Worldwork S.R.L (Montebello, IT). The FDA issued a Cleared decision on May 1, 2023, 202 days after receiving the submission on October 11, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070. Dental Amalgam Is A Device That Consists Of A Metallic Alloy, Such As Silver, Tin, Copper, And Zinc, That Is Mixed With Liquid Elemental Mercury For The Direct Filling Of Carious Lesions Or Structural Defects In Teeth.
| 510(k) Number | K223182 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | May 01, 2023 |
| Days to Decision | 202 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | OIV - Dental Amalgam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3070 |
| Definition | Dental Amalgam Is A Device That Consists Of A Metallic Alloy, Such As Silver, Tin, Copper, And Zinc, That Is Mixed With Liquid Elemental Mercury For The Direct Filling Of Carious Lesions Or Structural Defects In Teeth |