Data / Medical devices / Netherlands / Cavex Holland B.V.
Cavex Holland B.V.: FDA-registered device maker in HAARLEM Noord-Holland, Netherlands, 12 510(k) clearances
Cavex Holland B.V. is registered with the FDA (registration 9614573) in HAARLEM Noord-Holland, Netherlands. It lists 14 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 28, 2015. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9614573
- FEI number
- 3008898734
- Address
- Fustweg 5, HAARLEM Noord-Holland, Netherlands, 2031CJ
- Owner or operator
- CAVEX HOLLAND B.V. (9033296)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- February 4, 2000
- Registered through
- 2027
- Brand names listed
- Alginate Plus, Alginoplast, Cavex Bite&White, Cavex Bite&White ExSense, Cavex Bite&White StainLess, Cavex Bleach Transparant 1,0 mm, Cavex CA 37, Cavex CA37 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2015 | K151535 | Cavex Cream Alginate | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| November 8, 2007 | K072245 | EMULATE ADVANCED | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| July 10, 2006 | K061267 | SIMULATE, COLOR CHANGE ALGINATE | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| June 21, 2005 | K051207 | CAVEX ORTHOTRACE | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| November 24, 2004 | K042806 | QUADRANT UNIT-1-BOND | KLE | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| April 17, 2002 | K020242 | EMULATE FAST SET AND EMULATE REGULAR SET | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| July 16, 2001 | K011419 | CAVEX COLORCHANGE | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| January 23, 2001 | K003791 | CAVEX TEMPORARY CEMENT | EMA | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| May 25, 2000 | K000686 | KROM-ALGINATE AND ALGINATE PLUS | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| December 4, 1998 | K984043 | QUADRANT TOTAL ETCH | EBF | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| December 4, 1998 | K984041 | QUADRANT UNIVERSAL LC | EBF | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
| September 2, 1998 | K981970 | ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI | ELW | Substantially Equivalent | Cavex Holland BV | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Heat Source For Bleaching Teeth
- All makers of Material, Impression
- All makers of Plate, Base, Shellac
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Disinfectant, Medical Devices
Updated October 28, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.