Cleared Traditional

K811209 - JACOB WIRZ TRANSFIXATION PIN

K811209 is an FDA 510(k) clearance for JACOB WIRZ TRANSFIXATION PIN, manufactured by Colmed, Ltd.. The device is a Class 2 Dental device with product code ELS cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K811209 · Colmed, Ltd. · Dental device
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Jun 1981
Decision
46d
Days
Class 2
Risk

K811209 is an FDA 510(k) clearance for the JACOB WIRZ TRANSFIXATION PIN. Classified as Splint, Endodontic Stabilizing (product code ELS), Class II - Special Controls.

Submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3890 - 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 Colmed, Ltd. devices

FDA 510(k) Submission Details - K811209

510(k) Number K811209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1981
Decision Date June 16, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELS Device Classification - Class 2, Special Controls

Product Code ELS Splint, Endodontic Stabilizing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3890
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.