Cleared Traditional

K872471 - TITANE SL DENTAL BURR

K872471 is an FDA 510(k) clearance for TITANE SL DENTAL BURR, manufactured by Titane SL Co.. The device is a Class 1 Dental device with product code ECM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K872471 · Titane SL Co. · Dental device
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Sep 1987
Decision
80d
Days
Class 1
Risk

K872471 is an FDA 510(k) clearance for the TITANE SL DENTAL BURR. Classified as Band, Preformed, Orthodontic (product code ECM), Class I - General Controls.

Submitted by Titane SL Co. (Minneapolis, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - 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 Titane SL Co. devices

FDA 510(k) Submission Details - K872471

510(k) Number K872471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1987
Decision Date September 11, 1987
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

ECM Device Classification - Class 1, General Controls

Product Code ECM Band, Preformed, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.