Cleared Traditional

K913100 - PALFIQUE INLAY

K913100 is an FDA 510(k) clearance for PALFIQUE INLAY, 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 82-day FDA review.

K913100 · Tokuyama America, Inc. · Dental device
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Oct 1991
Decision
82d
Days
Class 2
Risk

K913100 is an FDA 510(k) clearance for the PALFIQUE INLAY. 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 October 2, 1991 after a review of 82 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 Tokuyama America, Inc. devices

FDA 510(k) Submission Details - K913100

510(k) Number K913100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1991
Decision Date October 02, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K913100.
SONO(R) -CEM
K913966 · Espe GmbH (Us) · Jan 1992
IMPERVA BOND
K913947 · Shofu Dental Corp. · Oct 1991
PALFIQUE LITEPOSTERIOR
K913099 · Tokuyama America, Inc. · Oct 1991
CURAY SUPPORT
K912788 · Scientific Pharmaceuticals, Inc. · Aug 1991
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · Kuraray Co. · Aug 1991
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991