Cleared Traditional

K924181 - POLIBOND

K924181 is an FDA 510(k) clearance for POLIBOND, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K924181 · Voco GmbH · Dental device
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Oct 1992
Decision
58d
Days
Class 2
Risk

K924181 is an FDA 510(k) clearance for the POLIBOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on October 16, 1992 after a review of 58 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 Voco GmbH devices

FDA 510(k) Submission Details - K924181

510(k) Number K924181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date October 16, 1992
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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 K924181.
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
OPTIBOND
K923546 · Kerr Corporation (Danbury) · Sep 1992
BISCO UNIVERSAL BOND-3
K923842 · Bisco, Inc. · Sep 1992
COLTENE A.R.T. BOND
K922615 · Coltene/Whaledent, Inc. · Aug 1992