Cleared Traditional

K130647 - XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML

Also marketed or referenced as:
XANTASIL FAST SET CARTRIDGE -6 X 50ML

K130647 is an FDA 510(k) clearance for XANTASIL DYNAMIX FAST SET CARTRIDGE -2 ..., manufactured by Heraeus Kulzer, LLC. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K130647 · Heraeus Kulzer, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
67d
Days
Class 2
Risk

K130647 is an FDA 510(k) clearance for the XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Heraeus Kulzer, LLC (South Bend, US). The FDA issued a Cleared decision on May 17, 2013 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 - K130647

510(k) Number K130647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date May 17, 2013
Days to Decision 67 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
61d faster than avg
Panel avg: 128d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 364
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K130647.
CORRECT PLUS 1
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