Cleared Traditional

K083062 - ROOT CANAL XR

K083062 is an FDA 510(k) clearance for ROOT CANAL XR, manufactured by S & C Polymer GmbH. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K083062 · S & C Polymer GmbH · Dental device
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Mar 2009
Decision
149d
Days
Class 2
Risk

K083062 is an FDA 510(k) clearance for the ROOT CANAL XR. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by S & C Polymer GmbH (Elmshorn, DE). The FDA issued a Cleared decision on March 12, 2009 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K083062

510(k) Number K083062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date March 12, 2009
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 128d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 - KIF Resin, Root Canal Filling

All 141
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K083062.
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MTA ROOT CANAL SEALER
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