Cleared Traditional

K041433 - BRIGHT GOLD XH

K041433 is the FDA 510(k) clearance for BRIGHT GOLD XH by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K041433 · Ivoclar Vivadent, Inc. · Dental device
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Aug 2004
Decision
83d
Days
Class 2
Risk

K041433 is an FDA 510(k) clearance for the BRIGHT GOLD XH. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on August 19, 2004 after a review of 83 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 Ivoclar Vivadent, Inc. devices

Submission Details

510(k) Number K041433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date August 19, 2004
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other 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 Peers - EJS Alloy, Other Noble Metal

All 110
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K041433.
SIMIDUR SUPERIOR
K040436 · Wieland Dental + Technik GmbH & Co. KG · Mar 2004
ECO E4
K022469 · Wieland Dental + Technik GmbH & Co. KG · Sep 2002
SIMIDUR S2
K020192 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
SIMIDUR KF PLUS
K020194 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
SIMIDUR S1S
K020195 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
D.SIGN 84
K014042 · Ivoclar Vivadent, Inc. · Feb 2002