Cleared Traditional

SR-IVOLEN TRAY MATERIAL (K863421) - FDA 510(k) Clearance

Class I Dental device.

K863421 · Ivoclar USA, Inc. · Dental device
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Nov 1986
Decision
60d
Days
Class 1
Risk

K863421 is an FDA 510(k) clearance for the SR-IVOLEN TRAY MATERIAL. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Ivoclar USA, Inc. (Chicago, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - 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 K863421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date November 03, 1986
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBH Material, Impression Tray, Resin

Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K863421.
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 1992
IMPRESSION TRAY
K872210 · Dentsply Intl. · Jun 1987
RESIN TRAY IMPRESSION MATERIAL
K854042 · Dentsply Intl. · Nov 1985
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE
K844471 · Dentsply Intl. · Feb 1985
HYBRID DENTAL PRODUCT
K813550 · Dentsply Intl. · Feb 1982
P-10 POSTERIOR FILLING MATERIAL
K802751 · 3M Company · Nov 1980