Cleared Traditional

CLEARFIL PHOTO BOND (K872959) - FDA 510(k) Clearance

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

K872959 · Kuraray Co. · Dental device
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Nov 1987
Decision
114d
Days
Class 2
Risk

K872959 is an FDA 510(k) clearance for the CLEARFIL PHOTO BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Co. (New York, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 Kuraray Co. devices

Submission Details

510(k) Number K872959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1987
Decision Date November 20, 1987
Days to Decision 114 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K872959.
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
TEMPORARY DISCLOSING SOLUTION
K874074 · Dentsply Intl. · Dec 1987
MODIFIED SELF-CURE BONDING AGENT
K863522 · Dentsply Intl. · Sep 1986
ETCH AND BOND
K852660 · Dentsply Intl. · Jul 1985
OPAQUER/BONDING AGENT
K851056 · Dentsply Intl. · Apr 1985