Cleared Traditional

K032116 - TULIP COLORSWITCH

K032116 is an FDA 510(k) clearance for TULIP COLORSWITCH, 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 83-day FDA review.

K032116 · Cavex Holland BV · Dental device
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Sep 2003
Decision
83d
Days
Class 2
Risk

K032116 is an FDA 510(k) clearance for the TULIP COLORSWITCH. 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 September 30, 2003 after a review of 83 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 - K032116

510(k) Number K032116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2003
Decision Date September 30, 2003
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 K032116.
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
K041229 · Cosmedent, Inc. · Jun 2004
FIT CHECKER II
K032289 · GC America, Inc. · Oct 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · Harry J. Bosworth Co. · Oct 2003
POLY Q (GARANT L, PENTA M, PENTA H)
K032001 · 3M Espe AG Dental Products · Aug 2003
P2 POLYETHER
K030318 · Heraeus Kulzer, Inc. · Apr 2003
EXAJET
K023751 · GC America, Inc. · Jan 2003