Cleared Traditional

K101215 - NUANCE

K101215 is an FDA 510(k) clearance for NUANCE, manufactured by Discus Dental, LLC. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K101215 · Discus Dental, LLC · Dental device
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May 2010
Decision
12d
Days
Class 2
Risk

K101215 is an FDA 510(k) clearance for the NUANCE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Discus Dental, LLC (Culver City, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 12 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 Discus Dental, LLC devices

FDA 510(k) Submission Details - K101215

510(k) Number K101215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2010
Decision Date May 12, 2010
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 713
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K101215.
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