Cleared Traditional

K954115 - ARTGLASS & KEVLOC

K954115 is the FDA 510(k) clearance for ARTGLASS & KEVLOC by Heraeus Kulzer, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K954115 · Heraeus Kulzer, Inc. · Dental device
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Sep 1995
Decision
58d
Days
Class 2
Risk

K954115 is an FDA 510(k) clearance for the ARTGLASS & KEVLOC. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on September 27, 1995 after a review of 58 days - a notably fast clearance cycle.

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: 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 Heraeus Kulzer, Inc. devices

Submission Details

510(k) Number K954115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date September 27, 1995
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 612
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K954115.
CRYSTALLESSENCE
K954988 · Confi-Dental Products Co. · Mar 1996
AELITEFLO
K955292 · Bisco, Inc. · Dec 1995
CHARISMA SINGLE DOSE
K954929 · Heraeus Kulzer, Inc. · Nov 1995
COMP=FLOW
K952662 · Jeneric/Pentron, Inc. · Aug 1995
ULTRADENT FLOWABLE COMPOSITE
K953525 · Ultradent Products, Inc. · Aug 1995
COMPSEAL
K952500 · Jeneric/Pentron, Inc. · Jun 1995