Cleared Traditional

NATURA-TONE OR LUXOPAL CL ACRYLIC (K842208) - FDA 510(k) Clearance

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

K842208 · Parexel Intl. Corp. · Dental device
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Jul 1984
Decision
57d
Days
Class 2
Risk

K842208 is an FDA 510(k) clearance for the NATURA-TONE OR LUXOPAL CL ACRYLIC. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Parexel Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1984 after a review of 57 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 Parexel Intl. Corp. devices

Submission Details

510(k) Number K842208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date July 31, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 127d · This submission: 57d
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

All 7
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K842208.
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
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