Cleared Traditional

K003153 - SOLOBOND PLUS

K003153 is the FDA 510(k) clearance for SOLOBOND PLUS by Voco GmbH. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K003153 · Voco GmbH · Dental device
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Nov 2000
Decision
36d
Days
Class 2
Risk

K003153 is an FDA 510(k) clearance for the SOLOBOND PLUS. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on November 15, 2000 after a review of 36 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

Submission Details

510(k) Number K003153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date November 15, 2000
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K003153.
XSE
K011167 · 3M Company · May 2001
EXCITE DSC
K003293 · Ivoclar North America, Inc. · Feb 2001
SELF ETCH BONDING PRIMER
K003011 · Jeneric/Pentron, Inc. · Nov 2000
PQ1
K000189 · Ultradent Products, Inc. · May 2000
KERR GEL ETCHANT
K000954 · Sybron Dental Specialties, Inc. · Apr 2000
BOND 1 C & B
K994359 · Jeneric/Pentron, Inc. · Mar 2000