Cleared Traditional

K033520 - BLUEPHASE

K033520 is an FDA 510(k) clearance for BLUEPHASE, 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 28-day FDA review.

K033520 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
28d
Days
Class 2
Risk

K033520 is an FDA 510(k) clearance for the BLUEPHASE. 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 December 5, 2003 after a review of 28 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.

View all Ivoclar Vivadent, Inc. devices

FDA 510(k) Submission Details - K033520

510(k) Number K033520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2003
Decision Date December 05, 2003
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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 143
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K033520.
LED TURBO-PEN
K041303 · Apoza Enterprise Co., Ltd. · Jun 2004
MINI L.E.D. OEM MODULE
K040808 · Satelec · Apr 2004
COLTOLUX LED CURING LIGHT
K040551 · Coltene/Whaledent, Inc. · Mar 2004
MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI
K032465 · Satelec · Oct 2003
SLED CURING LIGHT SYSTEM
K031615 · Dentsply International · Jul 2003
RADII
K030568 · Southern Dental Industries, Inc. · Apr 2003