CAVEX HOLLAND B.V.

FDA Device Registration & Listing · HAARLEM Noord-Holland, NL · Registration 9614573

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614573
FEI Number
3008898734
Entity Name
CAVEX HOLLAND B.V.
City/State/Country
HAARLEM Noord-Holland, NL
Establishment Address
FUSTWEG 5, HAARLEM Noord-Holland 2031CJ, NL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
CAVEX HOLLAND B.V. (Owner Number: 9033296)
Owner / Operator Contact Address
FUSTWEG 5, --, HAARLEM, NL-NH 2031CJ, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Maxima Krom-Alginate Maxima Alginate Plus Cavex Temporary Cement Provisa Cem Emulate Cavex Bite&White ExSense White Royale Extreme Cleaning Toothpaste White Royale Perfection Whitening Pen Cavex Bite&White Cavex Bite&White StainLess Cavex ImpreSafe Cavex Instant Stone Cavex Bleach Transparant 1,0 mm Cavex Cream Alginate Quadrant Uni-1-Bond Cavex Impressional Cavex CA37 Quadrant Total Etch Quadrant Universal LC Quadrant Core LC Quadrant UniChem Quadrant Anterior Shine Quadrant Flow Quadrant Posterior Dense Cavex Dental Baseplate Cavex Individual Trays Cavex RushBrush Emulate Advanced Cavex Orthotrace Tulip Cavex CA 37 Kromalginate Xantalgin Select Cavex ColorChange Alginoplast Cavex SiliconA Tulip ColorSwitch Cavex Impressional Emulate Xantalgin Crono Alginate Plus Cavex StabiSil Simulate Vibringe MARK3 Evolution Cavex ColorChange Cavex Prophy Paste

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELW Material, Impression Dental Class 2 872.3660 2021-08-12
EMA Cement, Dental Dental Class 2 872.3275 2007-12-05
ELW Material, Impression Dental Class 2 872.3660 2021-08-12
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2013-03-11
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2009-04-14
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2026-03-09
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2026-03-09
ELW Material, Impression Dental Class 2 872.3660 2016-03-30
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2021-08-12
ELW Material, Impression Dental Class 2 872.3660 2021-07-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2021-08-12
ELW Material, Impression Dental Class 2 872.3660 2016-04-11
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2007-12-05
EEA Plate, Base, Shellac Dental Class 1 872.6200 2002-02-12
EFW Toothbrush, Manual Dental Class 1 872.6855 2013-03-11
ELW Material, Impression Dental Class 2 872.3660 2007-12-05
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2013-03-11
ELW Material, Impression Dental Class 2 872.3660 2021-07-16
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2026-03-09

Official Correspondent

Milroy van der Bor

US Agent Details

Brad Wilkinson Business: Practicon Email: bwilkinson@practicon.com Phone: (252) 7525183

Related Public Records

Same Entity

CAVEX HOLLAND B.V.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13
K972485 Arent, Fox, Kintner, Plotkin & Kahn CIMPAT N 1997-09-08
K982895 Sterngold/Implamed STERNOMEGA COMPOMER CEMENT 1998-10-09
K033068 Voco GmbH IONOFIL COLOR AC 2003-10-31
K062064 Southern Dental Industries, Inc. RIVA BOND LC 2006-11-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614573. Last updated year: 2026. Please use registration number 9614573 when referencing this establishment in official correspondence.
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