Cleared Traditional

K897009 - PALFIQUE LIGHT BONDING AGENT

K897009 is an FDA 510(k) clearance for PALFIQUE LIGHT BONDING AGENT, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K897009 · Tokuyama America, Inc. · Dental device
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May 1990
Decision
153d
Days
Class 2
Risk

K897009 is an FDA 510(k) clearance for the PALFIQUE LIGHT BONDING AGENT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Tokuyama America, Inc. (Washington, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 153 days - an extended review cycle.

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 Tokuyama America, Inc. devices

FDA 510(k) Submission Details - K897009

510(k) Number K897009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date May 15, 1990
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
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 331
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K897009.
DEGUFILL (R) BOND
K901870 · Degussa AG · Aug 1990
DEGUFILL (R) ADHESIVE
K901871 · Degussa AG · Aug 1990
SYNTAC (DENTIN BONDING AGENT)
K901913 · Ivoclar North America, Inc. · Jun 1990
PERTAC BOND
K900558 · Espe GmbH (Us) · Apr 1990
ALL-BOND DENTIN BONDING SYSTEM
K897020 · Bisco, Inc. · Mar 1990
9.6% HYDROFLUORIC ACID GEL
K896655 · Pulpdent Corp. · Feb 1990