Cleared Traditional

WILDE ADHESIVE BONDING SYSTEM (K913581) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K913581.
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · Dentsply Intl. · Jun 1994
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989