Cleared Traditional

K872959 - CLEARFIL PHOTO BOND

K872959 is an FDA 510(k) clearance for CLEARFIL PHOTO BOND, manufactured by Kuraray Co.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

FDA 510(k) Submission Details - K872959

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
Combination Product No
PCCP Authorized No
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.

KLE Device Classification - Class 2, Special Controls

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 380
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K872959.
KETAC-GLAZE
K884752 · Espe GmbH (Us) · Jan 1989
XR PRIMER
K880684 · Kerr Corporation (Danbury) · May 1988
TEMPORARY DISCLOSING SOLUTION
K874074 · Dentsply Intl. · Dec 1987
CLEARFIL PORCELAIN BOND
K871636 · Kuraray Co. · Jul 1987
MODIFIED SELF-CURE BONDING AGENT
K863522 · Dentsply Intl. · Sep 1986
KERR PORCELITE
K860346 · Kerr Corporation (Danbury) · Mar 1986