Cleared Traditional

K121583 - CLEARFIL MAJESTY FLOW

K121583 is an FDA 510(k) clearance for CLEARFIL MAJESTY FLOW, manufactured by Kuraray Noritake Dental, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K121583 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
56d
Days
Class 2
Risk

K121583 is an FDA 510(k) clearance for the CLEARFIL MAJESTY FLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (New York, US). The FDA issued a Cleared decision on July 25, 2012 after a review of 56 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 Kuraray Noritake Dental, Inc. devices

FDA 510(k) Submission Details - K121583

510(k) Number K121583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2012
Decision Date July 25, 2012
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
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 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K121583.
DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
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