Cleared Traditional

K030206 - APEX 90

K030206 is an FDA 510(k) clearance for APEX 90, manufactured by We Dong Myung Dental Industrial Co., Ltd.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K030206 · We Dong Myung Dental Industrial Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
8d
Days
Class 2
Risk

K030206 is an FDA 510(k) clearance for the APEX 90. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by We Dong Myung Dental Industrial Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on January 29, 2003 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 - K030206

510(k) Number K030206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date January 29, 2003
Days to Decision 8 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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

Underwriters Laboratories, Inc.
CHAN YO WON

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 - EJT Alloy, Gold-based Noble Metal

All 626
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K030206.
AIGIS-XO
K024145 · Sb Lucius, Inc. · Mar 2003
AIGIS-A
K024140 · Sb Lucius, Inc. · Mar 2003
NEO 76
K024141 · Sb Lucius, Inc. · Mar 2003
UCP DENTAL MATERIAL
K023831 · Precious Chemicals U.S.A., Inc. · Jan 2003
UCC DENTAL MATERIAL
K023790 · Precious Chemicals U.S.A., Inc. · Jan 2003
GOLD CORE 35
K023501 · Pentron Laboratory Technologies · Dec 2002
K030206 · APEX 90
Download PDF FDA Summary We Dong Myung Dental …