Cleared Traditional

K897011 - PALFIQUE LIGHT-S COMPOSITE RESIN

K897011 is an FDA 510(k) clearance for PALFIQUE LIGHT-S COMPOSITE RESIN, manufactured by Tokuyama America, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K897011 · Tokuyama America, Inc. · Dental device
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May 1990
Decision
153d
Days
Class 2
Risk

K897011 is an FDA 510(k) clearance for the PALFIQUE LIGHT-S COMPOSITE RESIN. Classified as Material, Tooth Shade, Resin (product code EBF), 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 872.3690 - 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: 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 - K897011

510(k) Number K897011 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.

EBF Device Classification - Class 2, Special Controls

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 670
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K897011.
SILISTOR CERAMIC AND RESIN REPAIR SYSTEM
K901697 · Kulzer, Inc. · Jun 1990
EOS INLAY MATERIAL
K896469 · Ivoclar North America, Inc. · May 1990
PALFIQUE LIGHT COMPOSITE RESIN
K897010 · Tokuyama America, Inc. · May 1990
CONCEPT INLAY/ONLAY
K901396 · Ivoclar North America, Inc. · May 1990
FERMIT TEMPORARY MATERIAL
K896530 · Ivoclar North America, Inc. · May 1990
22% POLYACRYLIC ACID GEL
K901051 · Pulpdent Corp. · Apr 1990