Cleared Traditional

CERTAIN *DENTAL RESTORATIVE (K831559) - FDA 510(k) Clearance

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

K831559 · Johnson & Johnson Professionals, Inc. · Dental device
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Jun 1983
Decision
45d
Days
Class 2
Risk

K831559 is an FDA 510(k) clearance for the CERTAIN *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 June 30, 1983 after a review of 45 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 K831559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date June 30, 1983
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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 208
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K831559.
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
MICRODAPT DENTAL RESTORATIVE
K830380 · Johnson & Johnson Professionals, Inc. · Mar 1983
PRISMA-FINE
K830442 · Dentsply Intl. · Mar 1983
GAMMA LIGHT CURING DENTAL RESTORATIVE
K823185 · Johnson & Johnson Professionals, Inc. · Nov 1982