Cleared Traditional

K033435 - E-SARANG 86, DM78, DM55

K033435 is an FDA 510(k) clearance for E-SARANG 86, 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 15-day FDA review.

K033435 · 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
Nov 2003
Decision
15d
Days
Class 2
Risk

K033435 is an FDA 510(k) clearance for the E-SARANG 86, DM78, DM55. 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 November 12, 2003 after a review of 15 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 - K033435

510(k) Number K033435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2003
Decision Date November 12, 2003
Days to Decision 15 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
113d faster than avg
Panel avg: 128d · This submission: 15d
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.
MARC M MOUSER

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 K033435.
HERADOR EC, PF, C, H, NH, G, GG AND MP
K034049 · Heraeus Kulzer,GmbH · Mar 2004
GOLD DENTAL CASTING ALLOYS
K033279 · Bego U.S.A. · Jan 2004
APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82
K033446 · We Dong Myung Dental Industrial Co., Ltd. · Nov 2003
APPOLLO 3 ALLOY
K032320 · Dentsply International · Oct 2003
ORION E ALLOY
K032316 · Dentsply Intl. · Sep 2003
ORION GX ALLOY
K032317 · Dentsply Intl. · Sep 2003
K033435 · E-SARANG 86, DM78, DM55
Download PDF FDA Summary We Dong Myung Dental …