Cleared Traditional

DW246 #43 (K926177) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K926177 · Ivoclar North America, Inc. · Dental device
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Mar 1994
Decision
454d
Days
Class 2
Risk

K926177 is an FDA 510(k) clearance for the DW246 #43. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 454 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K926177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1992
Decision Date March 07, 1994
Days to Decision 454 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 127d · This submission: 454d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K926177.
AURIUM 239
K940579 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 6
K940580 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 9
K940610 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 1C
K940361 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 2B
K940434 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 54+2
K940435 · Argen Precious Metals, Inc. · Mar 1994