Registered with FDA

HANSAMED LIMITED dba CITAGENIX

Mississauga, Canada. Lists 9 dental device types with FDA across 1 registered establishment.

FDA owner/operator9076685Foreign exporterPrivate-label distributor

Device types listed: 9
Brands and models: 19
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1Canada

Devices listed with FDA

What HANSAMED LIMITED dba CITAGENIX currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Animal Source Bone Grafting MaterialNPM · Class 2	Bone grafts & membranes	Lister	CevOssPreservaRidgeThe GraftThe Graft Collagen	2019
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Lister	EclipseEclipse PuttyPreservaRidge	2014
Intraoral Animal Source BarrierNPL · Class 2	Bone grafts & membranes	Lister	NeomemNeomem FlexPlusThe Cover	2014
Human Source Bone Grafting MaterialNUN · Class 2	Bone grafts & membranes	Lister	C-Blast PuttyC-Graft PuttyDynaBlastDynaGraft-D	2014
Bone PlateJEY · Class 2	Maxillofacial plates & screws	Lister	Citagenix	2011
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Lister	Citagenix	2011
Intraosseous Fixation ScrewDZL · Class 2	Maxillofacial plates & screws	Lister	Citagenix	2011
Ac-Powered Direct Drive HandpieceEKX · Class 1	Dental handpieces	Lister	Penguin RFA	2017
Intraoral Synthetic BarrierNPK · Class 2	Bone grafts & membranes	Lister	Opentex	2025

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

HANSAMED LIMITED dba CITAGENIX 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: PURGO BIOLOGICS Inc. (4), Jeil Medical Corporation (3), Tellos Medical AB (1), Odontit S.A. (1), Hans Biomed Corp. (1), Biomatlante (1), Isotis NV (1), SeaSpine Orthopedics Corporation (1).

Decided	510(k)	Device	Applicant	Device type
24 Jul 2024	K230305	THE Graft Collagen	PURGO BIOLOGICS Inc.	NPM Animal Source Bone Grafting Material
6 Oct 2023	K230091	THE Cover	PURGO BIOLOGICS Inc.	NPL Intraoral Animal Source Barrier
11 May 2023	K222549	OpenTex	PURGO BIOLOGICS Inc.	NPK Intraoral Synthetic Barrier
20 Jul 2018	K173188	The Graft Natural Bone Substitute	PURGO BIOLOGICS Inc.	NPM Animal Source Bone Grafting Material
7 Jan 2016	K143445	Tellos ISQ Buddy	Tellos Medical AB	EKX Ac-Powered Direct Drive Handpiece
22 May 2014	K123876	SYNERGY	Odontit S.A.	NPM Animal Source Bone Grafting Material
10 Jan 2014	K130235	SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY	Hans Biomed Corp.	NUN Human Source Bone Grafting Material
15 Mar 2010	K093122	MBCP+	Biomatlante	LYC Synthetic Bone Grafting Material
2 Oct 2009	K091679	LEFORTE SYSTEM BONE PLATE	Jeil Medical Corporation	JEY Bone Plate
29 Mar 2006	K060332	ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY	Isotis NV	NUN Human Source Bone Grafting Material
29 Jul 2005	K043573	DYNAGRAFT II DENTAL	SeaSpine Orthopedics Corporation	NUN Human Source Bone Grafting Material
26 May 2005	K050669	JEIL BONE FIXATION SYSTEM	Jeil Medical Corporation	JEY Bone Plate
24 Feb 2004	K033767	DUAL TOP ANCHOR SYSTEM SCREWS	Jeil Medical Corporation	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
HANSAmed Limited DBA CitagenixFDA reg. 3004431266	Mississauga Ontario, Canada	Foreign exporter, Private-label distributor

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9076685). 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.