Data / Medical devices / United States / Nobel Biocare Procera, LLC

Nobel Biocare Procera, LLC: FDA-registered device maker in Mahwah, NJ, United States, 1 510(k) clearance

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

Nobel Biocare Procera, LLC is registered with the FDA (registration 3005031178) in Mahwah, NJ, United States. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 24, 2014. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005031178
Address: 800 Corporate Dr, Mahwah, NJ, United States, 07430
Owner or operator: Nobel Biocare Services AG (8030879)
Roles: Complaint file establishment, Contract manufacturer
First device listed: March 25, 2002
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 Remover and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Contract manufacturer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Contract manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Contract manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Contract manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Contract manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Contract manufacturer	accessdata.fda.gov
Teeth, Porcelain	ELL	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
July 24, 2014	K132749	NOBELPROCERA OVERDENTURE BAR	NHA	Substantially Equivalent	Nobel Biocare USA, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 29, 2021	87848	Class II	Terminated	NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and es	Not manufactured to specification	accessdata.fda.gov

Compare with other makers

Updated July 24, 2014. 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.