Medical Device Manufacturer · NL , Rw Haarlem (Holland)

Cavex Holland BV - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 1998

Recent clearances: Cavex Cream Alginate, MARK3, PROVISA CEM

26
Total
26
Cleared
0
Denied

Cavex Holland BV, is a dental device manufacturer based in Haarlem, Netherlands. Founded in 1908, the company develops and manufactures impression materials, whitening products, restorative materials, and related dental solutions for professionals and consumers.

Cavex has received 26 FDA 510(k) clearances from 26 total submissions, with no denied submissions on record. All cleared devices fall within the dental category. The company's regulatory history spans from 1998 to 2015. Cavex is currently inactive in the FDA 510(k) system, with no new clearances in more than five years; this profile reflects its historical regulatory record.

Recent cleared devices include alginate impression materials, color-change alginates, bonding systems, and temporary cements. The company is recognized for innovation in impression technology and has maintained partnerships with dental professionals and academic institutions to support product development.

Explore the complete list of device names, product codes, and clearance dates in the FDA 510(k) database.

FDA 510(k) Regulatory Record - Cavex Holland BV

26 devices
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