Cleared Traditional

K831095 - ROYALE II

K831095 is the FDA 510(k) clearance for ROYALE II by Factor, Ii, Inc.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K831095 · Factor, Ii, Inc. · Dental device
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Aug 1983
Decision
149d
Days
Class 2
Risk

K831095 is an FDA 510(k) clearance for the ROYALE II. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Factor, Ii, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Factor, Ii, Inc. devices

Submission Details

510(k) Number K831095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date August 31, 1983
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 151
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K831095.
BOSWORTH DENT-ALL
K840405 · Harry J. Bosworth Co. · May 1984
RESIL
K840548 · Parker Laboratories, Inc. · Apr 1984
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983
SOFTIC 49
K821230 · The Healthcare Group Laboratories, Inc. · May 1982
MAXUM DENTURE RESIN
K800400 · Dentsply Intl. · Mar 1980