Cleared Traditional

K850824 - PHOTO CLEARFIL A. A LIGHT CURED ADHES. ...

K850824 is the FDA 510(k) clearance for PHOTO CLEARFIL A. A LIGHT CURED ADHES. ... by Kuraray Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K850824 · Kuraray Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
39d
Days
Class 2
Risk

K850824 is an FDA 510(k) clearance for the PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Co. (New York, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 39 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 Kuraray Co. devices

Submission Details

510(k) Number K850824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1985
Decision Date April 08, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 127d · This submission: 39d
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 579
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K850824.
VISILUX 2 VISIBLE LIGHT CURING UNIT
K851459 · 3M Company · May 1985
KULZER DENTIN ADHESIVE
K850965 · Kulzer, Inc. · Apr 1985
TRIAD C & B MATERIAL
K850911 · Dentsply Intl. · Apr 1985
KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
K844662 · Kerr Corporation (Danbury) · Mar 1985
KERR GELLED PHOSPHORIC ACID ETCHANT
K843026 · Kerr Corporation (Danbury) · Sep 1984
EVER-BOND V GLASS LONOMER RESTORATIVE
K843072 · Kerr Corporation (Danbury) · Sep 1984