Manufacturer registered with FDA

Sudimplant SA

TOULOUSE, France. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator9084682Manufacturer

Device types listed: 2
Brands and models: 3
510(k) clearances: 22006–2007
Markets registered in: 678 registrations outside the US
Establishments: 1France

510(k) clearances per year, 2000–2026

Registered in 6 markets

Where regulators' registries name Sudimplant SA as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: FranceOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Sudimplant SA	2 clearances	2006–2007	Below
Canada	Health Canada	Registration holder	SUDIMPLANT	36	2004–2004	Pure Global AI
United Kingdom	MHRA	Manufacturer	Sudimplant	17	—	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	SUDIMPLANT SASSUDIMPLANT limited company	12	—	Pure Global AI
Taiwan	TFDA	Manufacturer	SUDIMPLANT	9	2005–2017	Pure Global AI
South Korea	MFDS	Manufacturer	SUDIMPLANT	4	2010–2010	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

Devices listed with FDA

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

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	TBR IDE@ CONICTBR Zirconnect	2006
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	TBR Zirconnect	2007

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

510(k) clearances

Clearances on which FDA names Sudimplant SA as the applicant.

Decided	510(k)	Device	Device type
9 Nov 2007	K070935	T.B.R. ZIRCONNECT	DZE Root-Form Endosseous Implant
16 Feb 2006	K050956	TBR IDEA CONIC/CONIC	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
SUDIMPLANT SAFDA reg. 3005643710	TOULOUSE Haute-Garonne, France	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9084682). 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.