510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813200Substantially Equivalent

Gdc-1136 Casting Alloy for Porcelain-Fu

Ney, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813200 is the FDA 510(k) clearance record for GDC-1136 CASTING ALLOY FOR PORCELAIN-FU, a class II device, cleared for Ney on under FDA product code EJS (Alloy, Other Noble Metal). FDA records list one 510(k) clearance for Ney. As of , FDA records show no recalls naming K813200.

Clearance record

Decision date
Received
(48 days to decision)
Product code
EJS Alloy, Other Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Ney 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EJS

Trailing 12 months

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

FDA records show no clearances under product code EJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJS, 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