510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053114Substantially Equivalent

Silverfil

Dunia Perwira Manufacturing Sdn. Bhd., Upm Serdang, Selangor, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053114 is the FDA 510(k) clearance record for SILVERFIL, a class II device, cleared for Dunia Perwira Manufacturing Sdn. Bhd. on under FDA product code EJJ (Alloy, Amalgam). FDA records list one 510(k) clearance for Dunia Perwira Manufacturing Sdn. Bhd. As of , FDA records show no recalls naming K053114.

Clearance record

Decision date
Received
(8 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Dunia Perwira Manufacturing Sdn. Bhd. Block G, Upm-Mtdc Technology, Upm Serdang, Selangor, MY
510(k) summary
Statement
Third party review
Yes

Clearances, product code EJJ

Trailing 12 months

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

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