Cleared Traditional

LC ChromeFlow (K222445) - FDA 510(k) Clearance

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

K222445 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
203d
Days
Class 2
Risk

K222445 is an FDA 510(k) clearance for the LC ChromeFlow. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on March 6, 2023 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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.

View all S&C Polymer Silicon- Und Composite Spezialitaten GmbH devices

Submission Details

510(k) Number K222445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2022
Decision Date March 06, 2023
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 317
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