Cleared Traditional

K905323 - WILL-CERAM Y AND WILL -CERAM Y-1

K905323 is the FDA 510(k) clearance for WILL-CERAM Y AND WILL -CERAM Y-1 by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K905323 · Ivoclar North America, Inc. · Dental device
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Dec 1990
Decision
26d
Days
Class 2
Risk

K905323 is an FDA 510(k) clearance for the WILL-CERAM Y AND WILL -CERAM Y-1. 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 December 24, 1990 after a review of 26 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 North America, Inc. devices

Submission Details

510(k) Number K905323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date December 24, 1990
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K905323.
DEGUDENT GS
K905387 · Degussa AG · Jan 1991
GDC-1501
K904695 · Deringer-Ney, Inc. · Jan 1991
THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
K905197 · Ormco Corp. · Dec 1990
WILL-CERAM W-1
K905324 · Ivoclar North America, Inc. · Dec 1990
MINIGOLD
K905326 · Ivoclar North America, Inc. · Dec 1990
HARMONY LINE ALLOYS
K905330 · Ivoclar North America, Inc. · Dec 1990