Cleared Traditional

K873123 - LEE COMPOSITE INLAY SYSTEM

K873123 is an FDA 510(k) clearance for LEE COMPOSITE INLAY SYSTEM, manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K873123 · Lee Pharmaceuticals · Dental device
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Jan 1988
Decision
163d
Days
Class 2
Risk

K873123 is an FDA 510(k) clearance for the LEE COMPOSITE INLAY SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (South El Monte, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 163 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 Lee Pharmaceuticals devices

FDA 510(k) Submission Details - K873123

510(k) Number K873123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date January 20, 1988
Days to Decision 163 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
36d slower than avg
Panel avg: 127d · This submission: 163d
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 800
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K873123.
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · Bisco, Inc. · Mar 1988
CLEARFIL PHOTO POSTERIOR
K872588 · Kuraray Co. · Mar 1988
BISCOLOR
K875256 · Bisco, Inc. · Feb 1988
CLEARFIL PORCELAIN REPAIR SYSTEM
K873886 · Kuraray Co. · Nov 1987
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · 3M Company · Sep 1987
DEN-MAT TENURE
K872510 · Den-Mat Corp. · Aug 1987