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Dentium USA: FDA-registered device maker in Cypress, CA, United States, 4 510(k) clearances

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

Dentium USA is registered with the FDA (registration 3005503242) in Cypress, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 23, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005503242
Address: 6761 Katella Ave., Cypress, CA, United States, 90630
Owner or operator: Dentium USA (9063757)
Roles: Manufacturer
First device listed: December 20, 2007
Registered through: 2026
Brand names listed: CMAB10HAL, CMAB10NA, CMAB14HAL, CMAB14NA, CMAB15HAL, CMAB15NA, CMAB30LH, CMAB30N and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	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
February 23, 2022	K213599	SuperLine	DZE	Substantially Equivalent	Dentium Co., Ltd.	accessdata.fda.gov
January 13, 2017	K160965	SuperLine	DZE	Substantially Equivalent	Dentium Co., Ltd.	accessdata.fda.gov
December 16, 2016	K161713	Dentium CAD/CAM Abutments	NHA	Substantially Equivalent	Dentium Co., Ltd.	accessdata.fda.gov
July 29, 2004	K041368	DENTIUM CO., LTD. IMPLANTIUM	DZE	Substantially Equivalent	Dentium Co., Ltd.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
June 29, 2007	38354	Not yet classified	Terminated	Biomedicare Implantium Fixtures, Model numbers : FX3408, FX3410, FX3412, FX3414, FX3808, FX3810, FX3812, FX3814, FX4308, FX4310, FX4312, FX4314, FX4808, FX4810, FX4812, FX4814, FX4814W	Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.	accessdata.fda.gov

Compare with other makers

Updated February 23, 2022. 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.