Cleared Traditional

K931162 - KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH

K931162 is an FDA 510(k) clearance for KING-HUE, manufactured by King Dental Corp.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K931162 · King Dental Corp. · Dental device
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May 1993
Decision
80d
Days
Class 2
Risk

K931162 is an FDA 510(k) clearance for the KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by King Dental Corp. (Miami, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 80 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 King Dental Corp. devices

FDA 510(k) Submission Details - K931162

510(k) Number K931162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1993
Decision Date May 27, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K931162.
ENIGMA DENTURE TEETH
K984128 · Davis Schottlander & Davis, Ltd. · Feb 1999
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
COMPATIT R
K913582 · Wilde-USA, Inc. · Jun 1993
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992