Cleared Traditional

K872588 - CLEARFIL PHOTO POSTERIOR

K872588 is an FDA 510(k) clearance for CLEARFIL PHOTO POSTERIOR, manufactured by Kuraray Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K872588 · Kuraray Co. · Dental device
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Mar 1988
Decision
245d
Days
Class 2
Risk

K872588 is an FDA 510(k) clearance for the CLEARFIL PHOTO POSTERIOR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Co. (New York, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 245 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 Kuraray Co. devices

FDA 510(k) Submission Details - K872588

510(k) Number K872588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1987
Decision Date March 02, 1988
Days to Decision 245 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
118d slower than avg
Panel avg: 127d · This submission: 245d
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 799
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K872588.
CLEARFIL PHOTO CORE
K882006 · Kuraray Co. · Jun 1988
G-CERA PORCELAIN BOND
K880765 · G-C Intl. Corp. · Apr 1988
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · Bisco, Inc. · Mar 1988
BISCOLOR
K875256 · Bisco, Inc. · Feb 1988
LEE COMPOSITE INLAY SYSTEM
K873123 · Lee Pharmaceuticals · Jan 1988
CLEARFIL PORCELAIN REPAIR SYSTEM
K873886 · Kuraray Co. · Nov 1987