Cleared Traditional

K844349 - SR VIVODENT PE ANTERIOR TEETH & SR ORTH...

K844349 is the FDA 510(k) clearance for SR VIVODENT PE ANTERIOR TEETH & SR ORTH... by Ivoclar USA, Inc.. It is a Class 2 Dental device (product code ELM) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K844349 · Ivoclar USA, Inc. · Dental device
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Dec 1984
Decision
24d
Days
Class 2
Risk

K844349 is an FDA 510(k) clearance for the SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Ivoclar USA, Inc. (Chicago, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 24 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 Ivoclar USA, Inc. devices

Submission Details

510(k) Number K844349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date December 03, 1984
Days to Decision 24 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 127d · This submission: 24d
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 17
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K844349.
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
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · Dentsply Intl. · Mar 1978