Cleared Traditional

K013275 - ASTRALIS 10

K013275 is the FDA 510(k) clearance for ASTRALIS 10 by Ivoclar Vivadent, Inc.. It is a Class 2 Dental device (product code EBZ) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K013275 · Ivoclar Vivadent, Inc. · Dental device
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Oct 2001
Decision
18d
Days
Class 2
Risk

K013275 is an FDA 510(k) clearance for the ASTRALIS 10, MODELS # 559588, 561859. 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 October 19, 2001 after a review of 18 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

Submission Details

510(k) Number K013275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2001
Decision Date October 19, 2001
Days to Decision 18 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
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K013275.
L.E.DEMETRON
K021797 · Sybron Dental Specialties, Inc. · Jun 2002
OPTILUX CURING LIGHTS
K020267 · Sybron Dental Specialties, Inc. · Mar 2002
ASTRALIS 7, MODEL 557545
K013277 · Ivoclar Vivadent, Inc. · Oct 2001
TRANSLUX ENERGY
K012341 · Heraeus Kulzer, Inc. · Aug 2001
GC E-LIGHT
K012134 · GC America, Inc. · Aug 2001
VERSALUX
K010133 · Centrix, Inc. · Apr 2001