Data / Medical devices / Sweden / Dentatus AB

Dentatus AB: FDA-registered device maker in SPANGA Stockholm, Sweden, 2 510(k) clearances

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

Dentatus AB is registered with the FDA (registration 8030870) in SPANGA Stockholm, Sweden. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 8, 2004. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030870
FEI number: 3006944200
Address: Finspangsgatan 42, SPANGA Stockholm, Sweden, SE-163 53
Owner or operator: DENTATUS AB (8030870)
Roles: Manufacturer, Repackager or relabeler
First device listed: June 22, 1981
Registered through: 2026
Brand names listed: AEB Facebow, AEC Facebow, AEE Facebow, AEK Facebow, AEP Facebow, AEV Facebow, ANEW, ARD and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Articulators	EJP	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Facebow	KCR	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Pin, Retentive And Splinting, And Accessory Instruments	EBL	1	Manufacturer	accessdata.fda.gov
Point, Abrasive	EHL	1	Manufacturer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	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
December 8, 2004	K042931	TUF LINK SILICONE RELINER	EBI	Substantially Equivalent	Dentatus USA , Ltd.	accessdata.fda.gov
September 13, 2004	K040143	MONORAIL	DZE	Substantially Equivalent	Nats Corp.	accessdata.fda.gov

Compare with other makers

Updated December 8, 2004. 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.