Cleared Traditional

ARTIC (K033628) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033628 · Heraeus Kulzer, Inc. · Dental device
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Jan 2004
Decision
58d
Days
Class 2
Risk

K033628 is an FDA 510(k) clearance for the ARTIC. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 K033628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2003
Decision Date January 16, 2004
Days to Decision 58 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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 ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K033628.
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · Dentsply Intl. · Mar 1978