510(k) K140125
K140125 is an FDA 510(k) premarket notification submitted by New Stetic for the device "NEW STETIC DENTAL AMALGAM ALLOY". The FDA issued a decision of Substantially Equivalent on April 29, 2014. The device falls under product code OIV (Dental Amalgam), a Class II device regulated under 21 CFR 872.3070. New Stetic has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2014
- Date Received
- January 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Amalgam
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type
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