Cleared Traditional

K913581 - WILDE ADHESIVE BONDING SYSTEM

K913581 is an FDA 510(k) clearance for WILDE ADHESIVE BONDING SYSTEM, manufactured by Wilde-USA, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 564-day FDA review.

K913581 · Wilde-USA, Inc. · Dental device
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Feb 1993
Decision
564d
Days
Class 2
Risk

K913581 is an FDA 510(k) clearance for the WILDE ADHESIVE BONDING SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on February 26, 1993 after a review of 564 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Wilde-USA, Inc. devices

FDA 510(k) Submission Details - K913581

510(k) Number K913581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1991
Decision Date February 26, 1993
Days to Decision 564 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 127d · This submission: 564d
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 347
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K913581.
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
PULPDENT UNFILLED DUAL CURE BONDING RESIN
K930989 · Pulpdent Corp. · Apr 1993
RESTOBOND 4
K924378 · Lee Pharmaceuticals · Mar 1993
CLEARFIL PORCELAIN BOND ACTIVATOR
K925404 · Kuraray Co. · Jan 1993
POLIBOND
K924181 · Voco GmbH · Oct 1992
OPTIBOND
K923546 · Kerr Corporation (Danbury) · Sep 1992