Cleared Traditional

K051782 - BLUEPHASE 16I

K051782 is an FDA 510(k) clearance for BLUEPHASE 16I, 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 81-day FDA review.

K051782 · Ivoclar Vivadent, Inc. · Dental device
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Sep 2005
Decision
81d
Days
Class 2
Risk

K051782 is an FDA 510(k) clearance for the BLUEPHASE 16I. 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 September 20, 2005 after a review of 81 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 - K051782

510(k) Number K051782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date September 20, 2005
Days to Decision 81 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
46d faster than avg
Panel avg: 127d · This submission: 81d
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
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