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)
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.

View all We Dong Myung Dental Industrial Co., Ltd. devices

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
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · 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.

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All 550
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