Cleared Traditional

K051050 - SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 (FDA 510(k) Clearance)

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

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

Submission Details

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.

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 417
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