Data / Medical devices / Sweden / Nobel Biocare AB, Produktion

Nobel Biocare AB, Produktion: FDA-registered device maker in KARLSKOGA Orebro, Sweden, 2 510(k) clearances

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

Nobel Biocare AB, Produktion is registered with the FDA (registration 9611993) in KARLSKOGA Orebro, Sweden. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 6, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 9611993
FEI number: 3002807693
Address: Dimbovagen 2, KARLSKOGA Orebro, Sweden, SE-691-51
Owner or operator: Nobel Biocare Services AG (8030879)
Roles: Contract manufacturer, Manufacturer
First device listed: July 8, 2003
Registered through: 2027
Brand names listed: 1st Generation Surgical Templates, NobelGuide, 2nd Generation Surgical Templates, NobelGuide, Abutment Release Pin, Abutment Replica Multi-unit, Abutment Replica Snappy, Abutment Retrieval Tools/Instruments Titanium, Abutment Retrieval Tools/Instruments Zirconia, Abutment Screw Branemark System and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Contract manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Irrigation Endosseous Dental Implant Drill Bits	QRQ	1	Contract manufacturer	accessdata.fda.gov
Prosthesis, Nose, Internal	FZE	2	Contract 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
August 6, 2026	K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw	NHA	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
February 18, 2026	K252197	Nobel Biocare S Series Implants	DZE	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov

Compare with other makers

Updated August 6, 2026. 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.