Cleared Traditional

K914476 - VITAPAN ACRYLIC DENTURE TEETH

K914476 is the FDA 510(k) clearance for VITAPAN ACRYLIC DENTURE TEETH by Vident. It is a Class 2 Dental device (product code ELM) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K914476 · Vident · Dental device
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Mar 1992
Decision
146d
Days
Class 2
Risk

K914476 is an FDA 510(k) clearance for the VITAPAN ACRYLIC DENTURE TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 146 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 Vident devices

Submission Details

510(k) Number K914476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date March 02, 1992
Days to Decision 146 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
19d slower than avg
Panel avg: 127d · This submission: 146d
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 15
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K914476.
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980