Cleared Traditional

K170873 - Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl (FDA 510(k) Clearance)

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

K170873 · Swissmeditec GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
193d
Days
Class 2
Risk

K170873 is an FDA 510(k) clearance for the Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posteri.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Swissmeditec GmbH (Finsterwald, CH). The FDA issued a Cleared decision on October 2, 2017 after a review of 193 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 Swissmeditec GmbH devices

Submission Details

510(k) Number K170873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2017
Decision Date October 02, 2017
Days to Decision 193 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 127d · This submission: 193d
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 926
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