Cleared Traditional

K960667 - CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE

K960667 is an FDA 510(k) clearance for CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE, manufactured by Wallace A. Erickson & Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K960667 · Wallace A. Erickson & Co. · Dental device
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Jul 1996
Decision
133d
Days
Class 2
Risk

K960667 is an FDA 510(k) clearance for the CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Wallace A. Erickson & Co. (Chicago, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 133 days - within the typical 510(k) review window.

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 Wallace A. Erickson & Co. devices

FDA 510(k) Submission Details - K960667

510(k) Number K960667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date July 02, 1996
Days to Decision 133 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
6d slower than avg
Panel avg: 127d · This submission: 133d
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 K960667.
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KOLOR +
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LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS
K960594 · Dent Zar, Inc. · Apr 1996
FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
K960595 · Dent Zar, Inc. · Apr 1996