Cleared Traditional

K921474 - VITA OMEGA PORCELAIN

K921474 is the FDA 510(k) clearance for VITA OMEGA PORCELAIN by Vident. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K921474 · Vident · Dental device
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Jun 1992
Decision
80d
Days
Class 2
Risk

K921474 is an FDA 510(k) clearance for the VITA OMEGA PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on June 18, 1992 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Vident devices

Submission Details

510(k) Number K921474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date June 18, 1992
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K921474.
DENTAL PORCELAIN
K921619 · Dentsply Intl. · Jul 1992
VITADUR ALPHA PORCELAIN
K921623 · Vident · Jul 1992
VITA IN-CERAM
K913644 · Vident · Jun 1992
NEW OPAQUE PORCELAIN
K915543 · Dentsply Intl. · Mar 1992
IPS EMPRESS
K913372 · Ivoclar North America, Inc. · Oct 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · Ivoclar North America, Inc. · Feb 1991