Cleared Traditional

K123397 - MULTILINK AUTOMIX

K123397 is an FDA 510(k) clearance for MULTILINK AUTOMIX, manufactured by Ivoclar Vivadent, AG. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K123397 · Ivoclar Vivadent, AG · Dental device
Download Printable Device Report (PDF)
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Jan 2013
Decision
87d
Days
Class 2
Risk

K123397 is an FDA 510(k) clearance for the MULTILINK AUTOMIX. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on January 31, 2013 after a review of 87 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 Ivoclar Vivadent, AG devices

FDA 510(k) Submission Details - K123397

510(k) Number K123397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2012
Decision Date January 31, 2013
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K123397.
CLEARFIL MAJESTY ES FLOW
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K123304 · Ivoclar Vivadent, AG · Jan 2013
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