Cleared Traditional

KORVIN VITA RADIOPAQUE PLASTIC TEETH (K844670) - FDA 510(k) Clearance

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

K844670 · Credent Co. · Dental device
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Apr 1985
Decision
129d
Days
Class 2
Risk

K844670 is an FDA 510(k) clearance for the KORVIN VITA RADIOPAQUE PLASTIC TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Credent Co. (Chicago, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 129 days - within the typical 510(k) review window.

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: 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 Credent Co. devices

Submission Details

510(k) Number K844670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1984
Decision Date April 08, 1985
Days to Decision 129 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 127d · This submission: 129d
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 K844670.
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