Data / Medical devices / United States / Dentamerica

Dentamerica: FDA-registered device maker in City of Industry, CA, United States, 6 510(k) clearances

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

Dentamerica is registered with the FDA (registration 2024949) in City of Industry, CA, United States. It lists 23 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 7, 2012. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2024949
Address: 18688 San Jose Ave, City of Industry, CA, United States, 91748
Owner or operator: DENTAMERICA (2024949)
Roles: Repackager or relabeler
First device listed: December 4, 2001
Registered through: 2026
Brand names listed: APIXIA DIGIREX, CAMMY, CELUX, DENTAL BUR, DENTAMERICA, ENDO FILE, EVERBRITE, LITEX and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Aligner, Beam, X-Ray	EHA	1	Repackager or relabeler	accessdata.fda.gov
Bur, Dental	EJL	1	Repackager or relabeler	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Repackager or relabeler	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Repackager or relabeler	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Repackager or relabeler	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Repackager or relabeler	accessdata.fda.gov
Illuminator, Radiographic-Film	IXC	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Hand, Calculus Removal	ELA	1	Repackager or relabeler	accessdata.fda.gov
Light, Fiber Optic, Dental	EAY	1	Repackager or relabeler	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	1	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Repackager or relabeler	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
May 7, 2012	K120106	APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM	MUH	Substantially Equivalent	Apixia, Inc.	accessdata.fda.gov
January 7, 2010	K092833	ENDOMAX CORDLESS ENDODONTIC HANDPIECE	EKX	Substantially Equivalent	Dentamerica	accessdata.fda.gov
April 24, 2006	K060640	DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM	EHD	Substantially Equivalent	Dentamerica	accessdata.fda.gov
January 29, 1998	K974704	HYDROGUM	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
January 18, 1996	K954820	SCALEX 800	ELC	Substantially Equivalent	Dentamerica	accessdata.fda.gov
January 2, 1996	K955759	LITEX 680	EBZ	Substantially Equivalent	Dentamerica	accessdata.fda.gov

Compare with other makers

Updated May 7, 2012. 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.