Cleared Traditional

K211212 - LoFric Elle

K211212 is the FDA 510(k) clearance for LoFric Elle by Dentsply Sirona. It is a Class 2 Gastroenterology & Urology device (product code EZD) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K211212 · Dentsply Sirona · Gastroenterology & Urology device
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Feb 2022
Decision
300d
Days
Class 2
Risk

K211212 is an FDA 510(k) clearance for the LoFric Elle. Classified as Catheter, Straight (product code EZD), Class II - Special Controls.

Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 17, 2022 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona devices

Submission Details

510(k) Number K211212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date February 17, 2022
Days to Decision 300 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 130d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZD Catheter, Straight
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EZD Catheter, Straight

All 47
Devices cleared under the same product code (EZD) and FDA review panel - the closest regulatory comparables to K211212.
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