Cleared Traditional

K020452 - HIGH SILVER CONVENTIONAL

K020452 is an FDA 510(k) clearance for HIGH SILVER CONVENTIONAL, manufactured by Ab Ardent. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K020452 · Ab Ardent · Dental device
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May 2002
Decision
85d
Days
Class 2
Risk

K020452 is an FDA 510(k) clearance for the HIGH SILVER CONVENTIONAL. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on May 7, 2002 after a review of 85 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 - K020452

510(k) Number K020452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date May 07, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 59
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K020452.
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
FUTURA TOPCAP NON GAMMA-2
K011801 · Ab Ardent · Aug 2001
ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY
K002808 · Nordiska Dental AB · Oct 2000
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
K002810 · Nordiska Dental AB · Oct 2000
K020452 · HIGH SILVER CONVENTIONAL
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