Cleared Traditional

K960165 - ALPHA-DENT COMPOSITE SURFACE SEALANT

K960165 is the FDA 510(k) clearance for ALPHA-DENT COMPOSITE SURFACE SEALANT by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K960165 · Wallace A. Erickson & Co. · Dental device
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Mar 1996
Decision
59d
Days
Class 2
Risk

K960165 is an FDA 510(k) clearance for the ALPHA-DENT COMPOSITE SURFACE SEALANT. 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 March 15, 1996 after a review of 59 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 Wallace A. Erickson & Co. devices

Submission Details

510(k) Number K960165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 15, 1996
Days to Decision 59 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
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 578
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K960165.
VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
K961434 · Vident · Jul 1996
CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE
K960667 · Wallace A. Erickson & Co. · Jul 1996
KOLOR +
K961284 · Sybron Dental Specialties, Inc. · May 1996
CRYSTALLESSENCE
K954988 · Confi-Dental Products Co. · Mar 1996
AELITEFLO
K955292 · Bisco, Inc. · Dec 1995
CHARISMA SINGLE DOSE
K954929 · Heraeus Kulzer, Inc. · Nov 1995