Not currently registered with FDA under this name

Acufex Microsurgical, Inc.

Mansfield, MA, United States. Named as applicant on 1 dental 510(k) clearance between 1992 and 1992. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11992–1992
Markets registered in: 24 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1990–2026

Registered in 2 markets

Where regulators' registries name Acufex Microsurgical, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Acufex Microsurgical, Inc.	1 clearances	1992–1992	Below
Taiwan	TFDA	Manufacturer	ACUFEX MICROSURGICAL, INC.	4	1988–1995	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Acufex Microsurgical, Inc. as the applicant.

Decided	510(k)	Device	Device type
24 Dec 1992	K922559	ACUFEX ENDOFIX BUTTON	EBG Resin Temporary Crown and Bridge

Sources

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 of the most recent filing, which can be a US agent.