Cleared Traditional

K091020 - BLUEPHASE 20I

K091020 is an FDA 510(k) clearance for BLUEPHASE 20I, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 2 Dental device with product code EBZ cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K091020 · Ivoclar Vivadent, Inc. · Dental device
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Jun 2009
Decision
64d
Days
Class 2
Risk

K091020 is an FDA 510(k) clearance for the BLUEPHASE 20I. Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on June 12, 2009 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - 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.

FDA 510(k) Submission Details - K091020

510(k) Number K091020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date June 12, 2009
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBZ Device Classification - Class 2, Special Controls

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
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 - EBZ Activator, Ultraviolet, For Polymerization

All 213
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K091020.
CL-DC20, CL-DC21
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LEDEX, MODEL: WL-070
K082408 · Dentmate Technology Co. , Ltd. · Dec 2008
SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
K081287 · Den-Mat Holdings, LLC · Nov 2008
K091020 · BLUEPHASE 20I
Download PDF Ivoclar Vivadent, Inc.