Cleared Traditional

K053114 - SILVERFIL

K053114 is an FDA 510(k) clearance for SILVERFIL, manufactured by Dunia Perwira Manufacturing Sdn. Bhd.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K053114 · Dunia Perwira Manufacturing Sdn. Bhd. · Dental device
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Nov 2005
Decision
8d
Days
Class 2
Risk

K053114 is an FDA 510(k) clearance for the SILVERFIL. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Dunia Perwira Manufacturing Sdn. Bhd. (Upm Serdang, Selangor, MY). The FDA issued a Cleared decision on November 15, 2005 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dunia Perwira Manufacturing Sdn. Bhd. devices

FDA 510(k) Submission Details - K053114

510(k) Number K053114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2005
Decision Date November 15, 2005
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 127d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJJ Alloy, Amalgam

All 44
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K053114.
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SECURALLOY
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