Cleared Traditional

K960365 - ALPHA-DENT HEMA DESENTIZER(748-000)/WIT...

K960365 is the FDA 510(k) clearance for ALPHA-DENT HEMA DESENTIZER(748-000)/WIT... by Wallace A. Erickson & Co.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K960365 · Wallace A. Erickson & Co. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
63d
Days
Class 2
Risk

K960365 is an FDA 510(k) clearance for the ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Wallace A. Erickson & Co. (Chicago, US). The FDA issued a Cleared decision on March 28, 1996 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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 K960365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date March 28, 1996
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K960365.
ULTRACID AND ULTRACID F DISINFECTING SOLUTION
K960697 · Ultradent Products, Inc. · May 1996
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K960823 · Dentsply Intl. · Apr 1996
CONFI-BOND
K955328 · Confi-Dental Products Co. · Mar 1996
AMALGAMIBOND PLUS
K960879 · Parkell, Inc. · Mar 1996
D-SENSE
K955279 · Centrix, Inc. · Dec 1995
SILANE PRIMER
K954708 · Sybron Dental Specialties, Inc. · Oct 1995