510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K032106Substantially Equivalent

Starbond Dental Bonding Alloys

Star Refining Precious Metals South Africa, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032106 is the FDA 510(k) clearance record for STARBOND DENTAL BONDING ALLOYS, a class II device, cleared for Star Refining Precious Metals South Africa on under FDA product code EJT (Alloy, Gold-Based Noble Metal). FDA records list 2 510(k) clearances for Star Refining Precious Metals South Africa, from to . As of , FDA records show no recalls naming K032106.

Clearance record

Decision date
Received
(48 days to decision)
Product code
EJT Alloy, Gold-Based Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Star Refining Precious Metals South Africa P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
Yes

Clearances, product code EJT

Trailing 12 months

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

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