K140125 is an FDA 510(k) clearance for the NEW STETIC DENTAL AMALGAM ALLOY. This device is classified as a Dental Amalgam (Class II - Special Controls, product code OIV).
Submitted by New Stetic (Apollo Beach, US). The FDA issued a Cleared decision on April 29, 2014, 103 days after receiving the submission on January 16, 2014.
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 | K140125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2014 |
| Decision Date | April 29, 2014 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| 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 |