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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 128d · 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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EJJ Alloy, Amalgam

All 71
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K053114.
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
K051010 · Septodont · May 2005
BESTALOY
K033434 · We Dong Myung Dental Industrial Co., Ltd. · Nov 2003
BENCO ADMIX
K032152 · Southern Dental Industries, Inc. · Aug 2003
BENCO SPHERICAL
K031658 · Southern Dental Industries, Inc. · Jul 2003
HIGH SILVER CONVENTIONAL
K020452 · Ab Ardent · May 2002
FUTURA TOPCAP NON GAMMA-2
K011801 · Ab Ardent · Aug 2001
K053114 · SILVERFIL
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