Cleared Traditional

K920893 - LITE FILL II P

K920893 is an FDA 510(k) clearance for LITE FILL II P, manufactured by Shofu Dental Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K920893 · Shofu Dental Corp. · Dental device
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Sep 1992
Decision
188d
Days
Class 2
Risk

K920893 is an FDA 510(k) clearance for the LITE FILL II P. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on September 1, 1992 after a review of 188 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 Shofu Dental Corp. devices

FDA 510(k) Submission Details - K920893

510(k) Number K920893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date September 01, 1992
Days to Decision 188 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
61d slower than avg
Panel avg: 127d · This submission: 188d
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 745
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K920893.
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
K921598 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
K921602 · Ultradent Products, Inc. · Sep 1992
LITE FIL II A
K920892 · Shofu Dental Corp. · Sep 1992
COMPOSITE RESIN CORE PASTE MATERIAL
K921174 · Centrix, Inc. · Sep 1992
PULPDENT HARD CORE
K922755 · Pulpdent Corp. · Aug 1992
TETRIC LIGHT-CURING COMPOSITE
K922569 · Ivoclar North America, Inc. · Jul 1992