Cleared Traditional

K061267 - SIMULATE

K061267 is an FDA 510(k) clearance for SIMULATE, 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 66-day FDA review.

K061267 · Cavex Holland BV · Dental device
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Jul 2006
Decision
66d
Days
Class 2
Risk

K061267 is an FDA 510(k) clearance for the SIMULATE, COLOR CHANGE ALGINATE. 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 July 10, 2006 after a review of 66 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 - K061267

510(k) Number K061267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2006
Decision Date July 10, 2006
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K061267.
EMULATE ADVANCED
K072245 · Cavex Holland BV · Nov 2007
IMPRESSIX, COLORCHANGE ALGINATE
K062400 · Cavex Holland BV · Nov 2006
VIRTUAL
K060891 · Ivoclar Vivadent, Inc. · Jul 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
EXPASYL POWER APPLICATOR
K051933 · Sybron Dental Specialties, Inc. · Jan 2006
IMPRESSIX
K052455 · Cavex Holland BV · Nov 2005