Manufacturer registered with FDA

Dhef Inc.

TAIPEI, Taiwan. Lists 18 dental device types with FDA across 1 registered establishment.

FDA owner/operator9004856Manufacturer

Device types listed: 18
Brands and models: 10
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1Taiwan

Devices listed with FDA

What Dhef Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	DRILLINTRAORAL	1995
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	POLYMAS Mouth Mirror & Accessories, Mirror Defogger, Dental Hand Instrument	2024
Dental Fiber Optic LightEAY · Class 1	Dental operating lights	Maker	FIBER OPTICLIGHT	1994
Dental Operating LightEAZ · Class 1	Dental operating lights	Maker	—	2012
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Maker	—	2010
Heat Source for Bleaching TeethEEG · Class 1	Teeth whitening lights	Maker	—	2010
X-Ray Film HolderEGZ · Class 1	—	Maker	—	2010
X-Ray Beam AlignerEHA · Class 1	—	Maker	—	2010
Extraoral with Timer X-Ray UnitEHD · Class 2	Dental X-ray units	Maker	—	2010
Prophylaxis CupEHK · Class 1	Polishing & prophylaxis	Maker	CUPPROPHYLAXIS	1995
Preformed Impression TrayEHY · Class 1	Impression trays	Maker	—	2010
Dental BurEJL · Class 1	Dental burs & diamonds	Maker	DENTAL BUR	2015
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Maker	ENDO FILE	2015
Ac-Powered Direct Drive HandpieceEKX · Class 1	Dental handpieces	Maker	—	2010
Calculus Removal Hand InstrumentELA · Class 1	Dental hand instruments	Maker	—	1992
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Maker	ULTRASONIC SCALER	2007
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Maker	—	2012
Accessories Operative Dental UnitNRD · Class 1	—	Maker	—	2011

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Dhef Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Dentamerica (4), Apixia, Inc. (1).

Decided	510(k)	Device	Applicant	Device type
7 May 2012	K120106	APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM	Apixia, Inc.	MUH Digital Extraoral Source X-Ray System
7 Jan 2010	K092833	ENDOMAX CORDLESS ENDODONTIC HANDPIECE	Dentamerica	EKX Ac-Powered Direct Drive Handpiece
24 Apr 2006	K060640	DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM	Dentamerica	EHD Extraoral with Timer X-Ray Unit
18 Jan 1996	K954820	SCALEX 800	Dentamerica	ELC Ultrasonic Scaler
2 Jan 1996	K955759	LITEX 680	Dentamerica	EBZ Ultraviolet Activator for Polymerization

Registered establishments

Establishment	Location	What it does
DHEF INC.FDA reg. 8043962	NEW TAIPEI CITY, Taiwan	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9004856). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.