Dental Device Guide
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Manufacturer registered with FDA

Cavex Holland BV

HAARLEM, Netherlands. Lists 13 dental device types with FDA across 1 registered establishment, and holds 26 510(k) clearances as applicant.

FDA owner/operator9033296Contract manufacturerForeign exporterManufacturerRepacker / relabeler
Device types listed
13
Brands and models
46
510(k) clearances
261998–2015
Markets registered in
15147 registrations outside the US
Establishments
1Netherlands
1998: 92000: 12001: 42002: 22003: 12004: 12005: 22006: 22007: 12008: 12014: 12015: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 15 markets

Where regulators' registries name Cavex Holland BV as the manufacturer or the registration holder of a device.

All markets
United States: 13 device types listedEuropean Union: 28 registrationsSouth Korea: 24 registrationsSaudi Arabia: 20 registrationsSerbia: 13 registrationsTaiwan: 13 registrationsColombia: 12 registrationsAustralia: 7 registrationsCosta Rica: 7 registrationsBrazil: 5 registrationsIsrael: 5 registrationsPeru: 5 registrationsEgypt: 3 registrationsUnited Kingdom: 3 registrationsChina: 2 registrations
RegisteredHome: NetherlandsOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCavex Holland BV26 clearances1998–2015Below
European UnionEUDAMEDManufacturerCavex Holland BV28—Pure Global AI
South KoreaMFDSManufacturerCAVEX HOLLAND B.V.Cavex Holland BV · Cavex Holland B.V. · +1241999–2025Pure Global AI
Saudi ArabiaSFDAManufacturerCavex Holland B.V.20—Pure Global AI
SerbiaALIMSManufacturerCavex Holland B.V.132021–2026Pure Global AI
TaiwanTFDAManufacturerCAVEX HOLLAND B.V.132011–2023Pure Global AI
ColombiaINVIMARegistration holderCAVEX HOLLAND BVCAVEX HOLLAND B.V.12—Pure Global AI
AustraliaTGAManufacturerCavex Holland BV72004–2020Pure Global AI
Costa RicaMinisterio de SaludManufacturerCAVEX HOLLAND B.V.7—Pure Global AI
BrazilANVISAManufacturerCAVEX HOLLAND B.V.52023–2025Pure Global AI
IsraelAMARManufacturerCAVEX HOLLAND BV5—Pure Global AI
PeruDIGEMIDManufacturerCAVEX HOLLAND B.V.52008–2024Pure Global AI
EgyptEDAManufacturerCAVEX HOLLAND B.V.,CAVEX HOLLAND BV,32024–2025Pure Global AI
United KingdomMHRAManufacturerCAVEX HOLLAND BV3—Pure Global AI
ChinaNMPARegistration holder荷兰佳贝士公司Cavex Holland BV荷兰佳贝士有限公司Cavex Holland B.V.2—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Cavex Holland BV currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Impression MaterialELW · Class 2Impression materialsMaker
Alginate PlusAlginoplastCavex CA 37Cavex CA37Cavex ColorChangeCavex Cream AlginateCavex ImpressionalCavex OrthotraceCavex SiliconACavex StabiSil
12 more
EmulateEmulate AdvancedEmulate ColorchangeKromalginateMARK3 EvolutionMaxima Alginate PlusMaxima Krom-AlginateSimulateTulipTulip ColorSwitchXantalgin CronoXantalgin Select
2007
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
Quadrant Anterior ShineQuadrant Core LCQuadrant FlowQuadrant Posterior DenseQuadrant Total EtchQuadrant UniChemQuadrant Universal LC
2007
Shellac Base PlateEEA · Class 1—Maker
Cavex Dental BaseplateCavex Individual Trays
2002
Heat Source for Bleaching TeethEEG · Class 1Teeth whitening lightsMaker
Cavex Bite&WhiteCavex Bite&White ExSenseCavex Bite&White StainLessWhite Royale Extreme Cleaning ToothpasteWhite Royale Perfection Whitening Pen
2013
Over the Counter Denture CleanserEFT · Class 1Denture cleansers & adhesivesMaker
Cavex GreenClean
2013
Manual ToothbrushEFW · Class 1ToothbrushesLister
Cavex RushBrush
2013
Intraoral Dental WaxEGD · Class 1—Maker
Cavex SetUp
2000
Preformed Impression TrayEHY · Class 1Impression traysLister
Cavex Bleach Transparant 1,0 mm
2026
Irrigating Endodontic Periodontic SyringeEIC · Class 1Dental hand instrumentsMaker
Vibringe
2013
Oral Cavity Abrasive Polishing AgentEJR · Class 1Polishing & prophylaxisMaker
Cavex Prophy Paste
2026
Dental CementEMA · Class 2Dental cementsMaker
Cavex Temporary CementProvisa Cem
2007
Resin Tooth Bonding AgentKLE · Class 2Bonding agentsMaker
Quadrant Uni-1-Bond
2021
Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2Denture resins & teethMaker
Cavex Instant Stone
2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Cavex Holland BV as the applicant.

Decided510(k)DeviceDevice type
28 Oct 2015K151535Cavex Cream AlginateELW Impression Material
4 Dec 2014K141092MARK3ELW Impression Material
31 Jan 2008K073539PROVISA CEMEMB Zinc Oxide Eugenol
8 Nov 2007K072245EMULATE ADVANCEDELW Impression Material
16 Nov 2006K062400IMPRESSIX, COLORCHANGE ALGINATEELW Impression Material
10 Jul 2006K061267SIMULATE, COLOR CHANGE ALGINATEELW Impression Material
23 Nov 2005K052455IMPRESSIXELW Impression Material
21 Jun 2005K051207CAVEX ORTHOTRACEELW Impression Material
24 Nov 2004K042806QUADRANT UNIT-1-BONDKLE Resin Tooth Bonding Agent
30 Sep 2003K032116TULIP COLORSWITCHELW Impression Material
13 Dec 2002K023466TULIP ALGINATE IMPRESSION MATERIALELW Impression Material
17 Apr 2002K020242EMULATE FAST SET AND EMULATE REGULAR SETELW Impression Material
29 Oct 2001K013336XANTALGIN CRONOELW Impression Material
19 Jul 2001K011452CAVEX STABISILELW Impression Material
16 Jul 2001K011419CAVEX COLORCHANGEELW Impression Material
23 Jan 2001K003791CAVEX TEMPORARY CEMENTEMA Dental Cement
25 May 2000K000686KROM-ALGINATE AND ALGINATE PLUSELW Impression Material
16 Dec 1998K984044QUADRANT POSTERIOR DENSEEBF Resin Tooth Shade Material
4 Dec 1998K984043QUADRANT TOTAL ETCHEBF Resin Tooth Shade Material
4 Dec 1998K984042QUADRANT CORE LCEBF Resin Tooth Shade Material
4 Dec 1998K984041QUADRANT UNIVERSAL LCEBF Resin Tooth Shade Material
30 Nov 1998K983751QUADRANT UNICHEMEBF Resin Tooth Shade Material
23 Nov 1998K983549QUADRANT ANTERIOR SHINEEBF Resin Tooth Shade Material
18 Nov 1998K983545QUADRANT UNIBONDKLE Resin Tooth Bonding Agent
2 Sep 1998K981970ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXIELW Impression Material
1 May 1998K980965SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIALELW Impression Material

Some of these clearances are listed with FDA today by another company: Wright Health Group (1).

Registered establishments

EstablishmentLocationWhat it does
CAVEX HOLLAND B.V.FDA reg. 9614573HAARLEM Noord-Holland, NetherlandsContract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9033296). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.