Data / Medical devices / Sweden / Directa AB

Directa AB: FDA-registered device maker in UPPLANDS VAESBY Stockholm, Sweden, 6 510(k) clearances

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

Directa AB is registered with the FDA (registration 8030938) in UPPLANDS VAESBY Stockholm, Sweden. It lists 32 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 18, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 8030938
FEI number: 3004586882
Address: Po Box 723 Finvids Vag 8, UPPLANDS VAESBY Stockholm, Sweden, 194 27
Owner or operator: DIRECTA AB (9004750)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: August 27, 1985
Registered through: 2027
Brand names listed: ANCHORAGE POST, Advance Dry Angle Tips, BURN OUT POST, Barb Broaches, Barman's Wedges, Big Apical Files, CAMO DENTAL SPLINT, CHEEK RETRACTOR and more

Devices it lists

Device	Product code	Class	Role	Source
Absorber, Saliva, Paper	KHR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Broach, Endodontic	EKW	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Cement, Dental	EMA	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Crown, Preformed	ELZ	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Exporter to the US	accessdata.fda.gov
Dam, Rubber	EIE	1	Repackager or relabeler	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Manufacturer	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Manufacturer	accessdata.fda.gov
Guard, Disk	EEJ	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Exporter to the US	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Exporter to the US	accessdata.fda.gov
Paper, Articulation	EFH	1	Manufacturer	accessdata.fda.gov
Plaque Disclosing Agent	QJC	1	Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer	accessdata.fda.gov
Post, Root Canal	ELR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer	accessdata.fda.gov
Reamer, Pulp Canal, Endodontic	EKP	1	Manufacturer	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Exporter to the US	accessdata.fda.gov
Retainer, Matrix	JEP	1	Manufacturer	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Manufacturer	accessdata.fda.gov
Strip, Polishing Agent	EHM	1	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	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 18, 2024	K241131	edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK	EBF	Substantially Equivalent	Edelweiss Dentistry Products GmbH	accessdata.fda.gov
November 20, 2020	K202413	LC ResinCal PC	EJK	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaten GmbH	accessdata.fda.gov
February 26, 2018	K170175	ENDOSEAL MTA	KIF	Substantially Equivalent	Maruchi	accessdata.fda.gov
March 19, 2012	K112078	ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)	KIF	Substantially Equivalent	Maruchi	accessdata.fda.gov
December 28, 2011	K113040	CERAMIR CROWN & BRIDGE	EMA	Substantially Equivalent	Doxa Dental AB	accessdata.fda.gov
December 8, 1989	K895508	CALASEPT PASTE	EJK	Substantially Equivalent	Js Dental Mfg., Inc.	accessdata.fda.gov

Compare with other makers

Updated October 18, 2024. 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.