Data / Medical devices / Germany / Dreve Dentamid GMBH

Dreve Dentamid GMBH: FDA-registered device maker in UNNA North Rhine-Westphalia, Germany, 6 510(k) clearances

Name: Dreve Dentamid GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dreve Dentamid GMBH is registered with the FDA (registration 1000486347) in UNNA North Rhine-Westphalia, Germany. It lists 11 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 7, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Dreve Dentamid GMBH

FDA registration number: 1000486347
Address: Max-Planck-Str. 31, UNNA North Rhine-Westphalia, Germany, 59423
Owner or operator: DREVE DENTAMID GMBH (9042374)
Roles: Contract manufacturer, Manufacturer
First device listed: December 28, 2004
Registered through: 2026
Brand names listed: Application tips, BioBleach hart/soft, Biolon, Drufolen H, Drufoplast, Drufosoft, Drufosoft pro, Dynax clear and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Contract manufacturer	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Material, Impression	ELW	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Plate, Base, Shellac	EEA	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	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
November 7, 2025	K250739	Primeprint Direct Aligner	NXC	Substantially Equivalent	Dreve Dentamid GmbH	accessdata.fda.gov
May 31, 2024	K241226	Fixtemp® C&B 4:1	EBG	Substantially Equivalent	Dreve Denatmid GmbH	accessdata.fda.gov
November 19, 2020	K200580	FotoDent denture	EBI	Substantially Equivalent	Dreve Dentamid GmbH	accessdata.fda.gov
November 7, 2019	K190571	StoneBite and StoneBite scan	ELW	Substantially Equivalent	Dreve Dentamid GmbH	accessdata.fda.gov
April 13, 2018	K171562	Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono	ELW	Substantially Equivalent	Dreve Dentamid GmbH	accessdata.fda.gov
April 5, 2018	K162408	Nano Varnish, Plaquit, Lightpaint on Surface	EBD	Substantially Equivalent	Dreve Dentamid GmbH	accessdata.fda.gov

Compare with other makers

Updated November 7, 2025. 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.