Cleared Traditional

K181500 - BRILLIANT Crios

K181500 is the FDA 510(k) clearance for BRILLIANT Crios by Coltene/Whaledent AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K181500 · Coltene/Whaledent AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
69d
Days
Class 2
Risk

K181500 is an FDA 510(k) clearance for the BRILLIANT Crios. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Coltene/Whaledent AG (Altstätten Sg, CH). The FDA issued a Cleared decision on August 15, 2018 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coltene/Whaledent AG devices

Submission Details

510(k) Number K181500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2018
Decision Date August 15, 2018
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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 Consultant

Emergo Global Consulting, LLC
Stuart R Goldman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 516
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K181500.
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