Cleared Traditional

K933831 - PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.

K933831 is an FDA 510(k) clearance for PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, manufactured by Nu-Dent, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K933831 · Nu-Dent, Inc. · Dental device
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Dec 1993
Decision
123d
Days
Class 2
Risk

K933831 is an FDA 510(k) clearance for the PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Nu-Dent, Inc. (New York, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 123 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 Nu-Dent, Inc. devices

FDA 510(k) Submission Details - K933831

510(k) Number K933831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1993
Decision Date December 06, 1993
Days to Decision 123 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
4d faster than avg
Panel avg: 127d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 263
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K933831.
KOOLINER II
K935261 · GC America, Inc. · Jan 1994
REBARON LC
K930939 · GC America, Inc. · Jan 1994
ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER
K934248 · Wallace A. Erickson & Co. · Dec 1993
DUAL CURE RELINE MATERIAL
K926406 · Dentsply Intl. · Mar 1993
PALABOND
K924422 · Heraeus Kulzer, Inc. · Nov 1992
PALADUR
K915898 · Heraeus Kulzer, Inc. · Sep 1992