Cleared Traditional

K051050 - SEBOND PINK LIGHT 5G

K051050 is an FDA 510(k) clearance for SEBOND PINK LIGHT 5G, manufactured by Schutz-Dental GmbH. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K051050 · Schutz-Dental GmbH · Dental device
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Jun 2005
Decision
65d
Days
Class 2
Risk

K051050 is an FDA 510(k) clearance for the SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, .... Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Schutz-Dental GmbH (Rosbach, DE). The FDA issued a Cleared decision on June 29, 2005 after a review of 65 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 Schutz-Dental GmbH devices

FDA 510(k) Submission Details - K051050

510(k) Number K051050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date June 29, 2005
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 337
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K051050.
MULTIPLE RESIN TOOTH BONDING AGENT
K052501 · Cosmedent, Inc. · Oct 2005
ECLIPSE BONDING AGENT
K051707 · Dentsply Intl. · Jul 2005
XENO ADHESIVE WITH ACTIVATOR
K051463 · Dentsply Intl. · Jul 2005
ALL-IN-ONE
K050647 · Bisco, Inc. · Apr 2005
ADHESIVE 1
K050331 · Southern Dental Industries, Inc. · Mar 2005
BOSWORTH BOND
K043170 · Harry J. Bosworth Co. · Feb 2005