Cleared Traditional

DENTACOLOR LIGHT CURING CROWN & BRIDGE (K831215) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 195
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K831215.
JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II)
K841518 · Johnson & Johnson Professionals, Inc. · May 1984
LIGHT CURED RESIN BONDED CERAMIC
K833797 · 3M Company · Apr 1984
LUXENE VINYL-JECT 3600-80
K834046 · Howmedica Corp. · Feb 1984
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