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Dhef Inc.: FDA-registered device maker in New Taipei City, Taiwan, 5 510(k) clearances

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

Dhef Inc. is registered with the FDA (registration 8043962) in New Taipei City, Taiwan. It lists 21 device types. The FDA files 5 510(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: 8043962
FEI number: 3002948158
Address: 15F., No. 104 & 106, Hsin Tai Wu RD. Sec. 1, Hsi Chih Dist., New Taipei City, Taiwan, --
Owner or operator: DHEF INC. (9004856)
Roles: Manufacturer
First device listed: March 3, 1992
Registered through: 2026
Brand names listed: CUP, DENTAL BUR, DRILL, ENDO FILE, FIBER OPTIC, INTRAORAL, LIGHT, POLYMAS Mouth Mirror & Accessories, Mirror Defogger, Dental Hand Instrument and more

Devices it lists

Device	Product code	Class	Role	Source
Activator, Ultraviolet, For Polymerization	EBZ	2	Manufacturer	accessdata.fda.gov
Aligner, Beam, X-Ray	EHA	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Cup, Prophylaxis	EHK	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Film, Radiographic	IWZ	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Manufacturer	accessdata.fda.gov
Holder, Film, X-Ray	EGZ	1	Manufacturer	accessdata.fda.gov
Illuminator, Radiographic-Film	IXC	1	Manufacturer	accessdata.fda.gov
Instrument, Hand, Calculus Removal	ELA	1	Manufacturer	accessdata.fda.gov
Light, Fiber Optic, Dental	EAY	1	Manufacturer	accessdata.fda.gov
Light, Operating, Dental	EAZ	1	Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	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
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 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.