Cleared Traditional

K111724 - STRAUMANN TIBRUSH (FDA 510(k) Clearance)

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

K111724 · Straumann USA · Dental device
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Sep 2011
Decision
84d
Days
Class 2
Risk

K111724 is an FDA 510(k) clearance for the STRAUMANN TIBRUSH. Classified as Scaler, Rotary (product code ELB), Class II - Special Controls.

Submitted by Straumann USA (Andover, US). The FDA issued a Cleared decision on September 12, 2011 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4840 - 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 Straumann USA devices

Submission Details

510(k) Number K111724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date September 12, 2011
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELB Scaler, Rotary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4840
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.