Cleared Traditional

K823185 - GAMMA LIGHT CURING DENTAL RESTORATIVE

K823185 is the FDA 510(k) clearance for GAMMA LIGHT CURING DENTAL RESTORATIVE by Johnson & Johnson Professionals, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K823185 · Johnson & Johnson Professionals, Inc. · Dental device
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Nov 1982
Decision
27d
Days
Class 2
Risk

K823185 is an FDA 510(k) clearance for the GAMMA LIGHT CURING DENTAL RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K823185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date November 22, 1982
Days to Decision 27 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
100d faster than avg
Panel avg: 127d · This submission: 27d
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 612
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K823185.
MICRODAPT DENTAL RESTORATIVE
K830380 · Johnson & Johnson Professionals, Inc. · Mar 1983
PRISMA-FINE
K830442 · Dentsply Intl. · Mar 1983
CURAY ANTERIOR/POSTERIOR RESTORATIVE
K823510 · Scientific Pharmaceuticals, Inc. · Dec 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982
VISIO-OPAQUER
K822453 · Espe GmbH (Us) · Sep 1982
ZEON COMPOSITE RESIN LIGHT CURE SYS
K820028 · National Patent Development Corp. · Mar 1982