Cleared Traditional

K964772 - AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)

K964772 is an FDA 510(k) clearance for AQUARIUS HPF (WILL BE SOLD AS WILLIAMS ..., manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K964772 · Ivoclar North America, Inc. · Dental device
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Jan 1997
Decision
51d
Days
Class 2
Risk

K964772 is an FDA 510(k) clearance for the AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS). 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 January 17, 1997 after a review of 51 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

FDA 510(k) Submission Details - K964772

510(k) Number K964772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1996
Decision Date January 17, 1997
Days to Decision 51 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
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 551
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