Cleared Traditional

K960879 - AMALGAMIBOND PLUS

K960879 is an FDA 510(k) clearance for AMALGAMIBOND PLUS, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K960879 · Parkell, Inc. · Dental device
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Mar 1996
Decision
18d
Days
Class 2
Risk

K960879 is an FDA 510(k) clearance for the AMALGAMIBOND PLUS. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 18 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 Parkell, Inc. devices

FDA 510(k) Submission Details - K960879

510(k) Number K960879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date March 22, 1996
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

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 372
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K960879.
PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
K960823 · Dentsply Intl. · Apr 1996
CONFI-BOND
K955328 · Confi-Dental Products Co. · Mar 1996
ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)
K960365 · Wallace A. Erickson & Co. · Mar 1996
GLUFLORMA
K955740 · Midwest Orthodontic Mfg. · Feb 1996
D-SENSE
K955279 · Centrix, Inc. · Dec 1995
AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER
K954133 · American Dental Products, Inc. · Oct 1995