Cleared Traditional

K905328 - WILL-CERAM BRUSHES

K905328 is the FDA 510(k) clearance for WILL-CERAM BRUSHES by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K905328 · Ivoclar North America, Inc. · Dental device
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Jan 1991
Decision
50d
Days
Class 2
Risk

K905328 is an FDA 510(k) clearance for the WILL-CERAM BRUSHES, SUPER BRUSH KIT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on January 17, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 K905328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date January 17, 1991
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 275
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K905328.
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
IPS EMPRESS
K913372 · Ivoclar North America, Inc. · Oct 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · Ivoclar North America, Inc. · Feb 1991
VMK 68 AND VMK 68N DENTAL PORCELAIN KIT
K901862 · Vident · Oct 1990
VITACHROM-L DENTAL PORCELAIN KIT
K901982 · Vident · Oct 1990
VITADUR-N DENTAL PORCELAIN KIT
K902105 · Vident · Oct 1990