510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140125Substantially Equivalent

New Stetic Dental Amalgam Alloy

New Stetic, Apollo Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140125 is the FDA 510(k) clearance record for NEW STETIC DENTAL AMALGAM ALLOY, a class II device, cleared for New Stetic on under FDA product code OIV (Dental Amalgam). FDA's definition for product code OIV reads: "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". FDA records list 5 510(k) clearances for New Stetic, from to . As of , FDA records show no recalls naming K140125.

Clearance record

Decision date
Received
(103 days to decision)
Product code
OIV Dental Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
New Stetic 445 Apollo Beach Blvd., Apollo Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OIV

Trailing 12 months

FDA records hold no clearances under product code OIV in the trailing twelve months.

FDA records show no clearances under product code OIV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260