Cleared Traditional

K831215 - DENTACOLOR LIGHT CURING CROWN & BRIDGE

K831215 is an FDA 510(k) clearance for DENTACOLOR LIGHT CURING CROWN & BRIDGE, manufactured by Kulzer, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K831215 · Kulzer, Inc. · Dental device
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Sep 1983
Decision
151d
Days
Class 2
Risk

K831215 is an FDA 510(k) clearance for the DENTACOLOR LIGHT CURING CROWN & BRIDGE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kulzer, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 151 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 Kulzer, Inc. devices

FDA 510(k) Submission Details - K831215

510(k) Number K831215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1983
Decision Date September 12, 1983
Days to Decision 151 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 127d · This submission: 151d
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 801
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K831215.
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
LIGHT CURING BONDING AGENT
K832061 · Johnson & Johnson Professionals, Inc. · Aug 1983
ADAPTIC*FAST SET DENTAL RESTORATIVE
K832062 · Johnson & Johnson Professionals, Inc. · Aug 1983
CERTAIN *DENTAL RESTORATIVE
K831559 · Johnson & Johnson Professionals, Inc. · Jun 1983