Cleared Traditional

K160049 - Charisma

K160049 is an FDA 510(k) clearance for Charisma, manufactured by Heraeus Kulzer, LLC, Mitsui Chemicals Group. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K160049 · Heraeus Kulzer, LLC, Mitsui Chemicals Group · Dental device
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Nov 2016
Decision
309d
Days
Class 2
Risk

K160049 is an FDA 510(k) clearance for the Charisma. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC, Mitsui Chemicals Group (South Bend, US). The FDA issued a Cleared decision on November 15, 2016 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K160049

510(k) Number K160049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2016
Decision Date November 15, 2016
Days to Decision 309 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
181d slower than avg
Panel avg: 128d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 863
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K160049.
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