Cleared Traditional

K914476 - VITAPAN ACRYLIC DENTURE TEETH

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

K914476 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K914476

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.

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 27
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K914476.
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
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160 · Austenal Dental, Inc. · Oct 1985
DELTA TEETH
K831214 · Dentsply Intl. · May 1983