Cleared Traditional

K013336 - XANTALGIN CRONO

K013336 is an FDA 510(k) clearance for XANTALGIN CRONO, manufactured by Cavex Holland BV. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K013336 · Cavex Holland BV · Dental device
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Oct 2001
Decision
20d
Days
Class 2
Risk

K013336 is an FDA 510(k) clearance for the XANTALGIN CRONO. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cavex Holland BV (Haarlem, NL). The FDA issued a Cleared decision on October 29, 2001 after a review of 20 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.

View all Cavex Holland BV devices

FDA 510(k) Submission Details - K013336

510(k) Number K013336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2001
Decision Date October 29, 2001
Days to Decision 20 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
107d faster than avg
Panel avg: 127d · This submission: 20d
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 195
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K013336.
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410 · Dentsply Intl. · May 2002
EMULATE FAST SET AND EMULATE REGULAR SET
K020242 · Cavex Holland BV · Apr 2002
CEREC3 VITABLOCKS
K012517 · Sirona Dental Systems GmbH · Nov 2001
STATUSBLUE
K013237 · Dmg USA, Inc. · Oct 2001
LUXABITE
K013236 · Dmg USA, Inc. · Oct 2001
EXTRUDE MODIFIED
K012405 · Sybron Dental Specialties, Inc. · Sep 2001