Cleared Traditional

K831351 - PERMALUX VISIBLE CURE COMPOSITE RESTOR

K831351 is an FDA 510(k) clearance for PERMALUX VISIBLE CURE COMPOSITE RESTOR, manufactured by Lares Manufacturing Co., Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K831351 · Lares Manufacturing Co., Inc. · Dental device
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Nov 1983
Decision
203d
Days
Class 2
Risk

K831351 is an FDA 510(k) clearance for the PERMALUX VISIBLE CURE COMPOSITE RESTOR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Lares Manufacturing Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Lares Manufacturing Co., Inc. devices

FDA 510(k) Submission Details - K831351

510(k) Number K831351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date November 14, 1983
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 128d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K831351.
MATERIAL TOOTHSADE RESIN
K834247 · Scientific Pharmaceuticals, Inc. · Feb 1984
VISIO-GEM
K833757 · Espe GmbH (Us) · Feb 1984
LUXENE VINYL-JECT 3600-80
K834046 · Howmedica Corp. · Feb 1984
CURAY-SUPPORT, CORE BUILD-UP MATERIAL
K832781 · Scientific Pharmaceuticals, Inc. · Oct 1983
DENTACOLOR LIGHT CURING CROWN & BRIDGE
K831215 · Kulzer, Inc. · Sep 1983
LIGHT CURING BONDING AGENT
K832061 · Johnson & Johnson Professionals, Inc. · Aug 1983