Cleared Traditional

K926556 - VIVALUX

K926556 is an FDA 510(k) clearance for VIVALUX, manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K926556 · Ivoclar North America, Inc. · Dental device
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Apr 1993
Decision
113d
Days
Class 2
Risk

K926556 is an FDA 510(k) clearance for the VIVALUX. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on April 23, 1993 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar North America, Inc. devices

FDA 510(k) Submission Details - K926556

510(k) Number K926556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date April 23, 1993
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 798
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K926556.
VARIOLINK
K931309 · Ivoclar North America, Inc. · Jul 1993
CHARISMA -- MODIFIED
K932013 · Heraeus Kulzer, Inc. · Jul 1993
DENTIN BONDING AGENT
K920533 · Confi-Dental Products Co. · May 1993
CLIP
K926418 · Voco GmbH · Mar 1993
PULPDENT DENTAL BOND ENCHANCER
K926074 · Pulpdent Corp. · Mar 1993
PHOTO CLEARFIL OPAQUER
K925383 · Kuraray Co. · Jan 1993