Dental Device Guide
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Manufacturer registered with FDA

Medtronic, Inc.

Minneapolis, MN, United States. Lists 7 dental device types with FDA across 8 registered establishments, and holds 11 510(k) clearances as applicant.

FDA owner/operator2112641ManufacturerSpecification developer
Device types listed
7
Brands and models
17
510(k) clearances
111985–2014
Markets registered in
186,991 registrations outside the US
Establishments
8Germany, India, United States
1985: 12001: 12005: 12006: 12009: 12010: 12011: 12012: 22013: 12014: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 18 markets

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

All markets
United States: 7 device types listedCanada: 1,414 registrationsSaudi Arabia: 1,230 registrationsBrazil: 609 registrationsEuropean Union: 589 registrationsSouth Korea: 585 registrationsColombia: 495 registrationsTaiwan: 434 registrationsPeru: 379 registrationsIsrael: 352 registrationsSerbia: 260 registrationsAustralia: 199 registrationsCosta Rica: 187 registrationsUnited Kingdom: 113 registrationsChina: 90 registrationsHong Kong: 51 registrationsEgypt: 3 registrationsBangladesh: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMedtronic, Inc.11 clearances1985–2014Below
CanadaHealth CanadaRegistration holderMEDTRONIC SOFAMOR DANEK USA, INC.MEDTRONIC XOMED INC. · OSTEOTECH INC1,4141999–2026Pure Global AI
Saudi ArabiaSFDAManufacturerMedtronic Sofamor Danek USA, Inc.Medtronic XOMED, Inc · Medtronic Sofamor Danek USA Inc.1,230—Pure Global AI
BrazilANVISAManufacturerMEDTRONIC, INC.MEDTRONIC SOFAMOR DANEK USA, INC. · MEDTRONIC INC · +26091999–2026Pure Global AI
European UnionEUDAMEDRegistration holderMedtronic, Inc.Medtronic Sofamor Danek USA, Inc. · Medtronic Xomed Inc589—Pure Global AI
South KoreaMFDSManufacturerMedtronic Sofamor Danek USA, Inc.Warsaw Orthopedic, Inc · Warsaw Orthopedic, Inc. · +25851998–2026Pure Global AI
ColombiaINVIMAManufacturerMEDTRONIC XOMED INC.MEDTRONIC INC · MEDTRONIC SOFAMOR DANEK USA, INC · +2495—Pure Global AI
TaiwanTFDAManufacturerMedtronic Inc.MEDTRONIC XOMED, INC. · MEDTRONIC SOFAMOR DANEK USA, INC. · +24341980–2026Pure Global AI
PeruDIGEMIDManufacturerMEDTRONIC SOFAMOR DANEK USA, INCMEDTRONIC INC · MEDTRONIC, INC · +23792015–2026Pure Global AI
IsraelAMARManufacturerMedtronic Inc.Medtronic, Inc. · Medtronic Sofamor Danek USA Inc. · +2352—Pure Global AI
SerbiaALIMSManufacturerMedtronic Sofamor Danek USA, Inc.Medtronic Xomed, Inc.2602021–2026Pure Global AI
AustraliaTGAManufacturerMedtronic Sofamor Danek USA IncMedtronic Xomed Inc · Osteotech Inc1992003–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerMEDTRONIC SOFAMOR DANEK USA, INC.MEDTRONIC XOMED, INC. · Medtronic Sofamor Danek USA., Inc · +2187—Pure Global AI
United KingdomMHRAManufacturerMedtronic Xomed Inc113—Pure Global AI
ChinaNMPARegistration holder美敦力枢法模丹历股份有限公司Medtronic Sofamor Danek USA, Inc.美国美敦力施美敦股份有限公司Medtronic Xomed, Inc. · 美敦力枢法模丹历股份有限公司Medtronic Sofamor Danek USA,Inc. · +290—Pure Global AI
Hong KongMDDManufacturerMedtronic Sofamor Danek USA, Inc.Medtronic Xomed, Inc. · Medtronic Sofamor Danek USA Inc512015–2026Pure Global AI
EgyptEDAManufacturerMedtronic Xomed, INC,Medtronic XOMED , INC ,,32016–2016Pure Global AI
BangladeshDGDAManufacturerMedtronic Sofamor Danek, USA12017–2017Pure 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 Medtronic, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Bone PlateJEY · Class 2Maxillofacial plates & screwsMaker
ARCHITEXMACROPORE FX, PS, NS, LPMACROPORE PROTECTIVE SHEETMACROPORE-PX PEDIATRIC SYSTEMTIMESH TITANIUM MINI-SOFTPLATE & MICRO-SOFT PLATE/SCREW SYSTEMTIMESH TITANIUM MINI-SOFTPLATE/SCRETISMESH SYSTEM
2006
Synthetic Bone Grafting MaterialLYC · Class 2Bone grafts & membranesMaker
Mastergraft Mini GranulesMASTERGRAFT PUTTY
2010
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
ARCHITEX
2011
Human Source Bone Grafting MaterialNUN · Class 2Bone grafts & membranesMaker
Grafton DBMGrafton DBM PasteGrafton DBM Plus
2011
Anti-Snoring DeviceLRK · Class 2Anti-snoring & jaw-repositioning devicesMaker
AirvanceAnti-snoring device
2009
Dental Bone Grafting Material with Biologic ComponentNPZ · Class 3—Maker
INFUSE BONGRAFT for Oral Max
2008
Animal Source Bone Grafting MaterialNPM · Class 2Bone grafts & membranesMaker
MASTERGRAFT Putty
2015

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 Medtronic, Inc. as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
10 Jun 2014K140374MASTERGRAFT PUTTYLYC Synthetic Bone Grafting Material
10 Jan 2013K122391MEDTRONIC XOMED, INC.LRK Anti-Snoring Device
30 May 2012K120271ARTISAN SPACE MAINTENANCE SYSTEMJEY Bone Plate
10 Feb 2012K110623PILLAR PALATAL IMPLANT SYSTEMLRK Anti-Snoring Device
13 Apr 2011K110259ARCHITEX SPACE MAINTENANCE SYSTEMJEY Bone Plate
13 Dec 2010K100779SUSTAIN SPACE MAINTENANCE SYSTEMJEY Bone Plate
30 Dec 2009K092087MEDTRONIC DENTAL TCPLYC Synthetic Bone Grafting Material
3 Jan 2006K051188GRAFTON DBMNUN Human Source Bone Grafting Material
30 Nov 2005K042707GRAFTON PLUS DBM PASTENUN Human Source Bone Grafting Material
5 Jun 2001K010701MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLERLYC Synthetic Bone Grafting Material
7 Oct 1985K852199OSTEOGRAF 2040 OSTEOGRAF 4060LYC Synthetic Bone Grafting Material

Also lists devices cleared under other names

Medtronic, 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: Medtronic Sofamor Danek (2), Macropore Biosurgery, Inc. (2), Ti-Mesh, Inc. (2), Influence, Inc. (1), Pacific Materials and Interfaces (1), Sofamor Danek USA,Inc. (1).

Decided510(k)DeviceApplicantDevice type
9 Jan 2009K082917MASTERGRAFT RESORBABLE CERAMIC GRANULESMedtronic Sofamor DanekLYC Synthetic Bone Grafting Material
17 Sep 2008K081784MASTERGRAFT PUTTYMedtronic Sofamor DanekLYC Synthetic Bone Grafting Material
18 Sep 2001K012413MACROPORE FX, PS, NS, LPMacropore Biosurgery, Inc.JEY Bone Plate
11 Jul 2001K002207MACROPOREPX PEDIATRIC SYSTEMMacropore Biosurgery, Inc.JEY Bone Plate
27 Aug 1999K981677REPOSE BONE SCREW SYSTEMInfluence, Inc.LRK Anti-Snoring Device
19 Mar 1999K983360MACROPORE PROTECTIVE SHEETPacific Materials and InterfacesJEY Bone Plate
19 Nov 1997K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEMSofamor Danek USA,Inc.JEY Bone Plate
8 Apr 1993K923419TISMESH SYSTEMTi-Mesh, Inc.JEY Bone Plate
26 Oct 1992K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREWTi-Mesh, Inc.JEY Bone Plate

Registered establishments

EstablishmentLocationWhat it does
Medtronic Engineering and Innovation Center (MEIC)FDA reg. 3018094310Hyderabad Telangana, IndiaComplaint file establishment
Medtronic NeurosurgeryFDA reg. 3015531529Fort Worth, TX, United StatesSpecification developer
MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBHFDA reg. 3011795235DEGGENDORF Bavaria, GermanyManufacturer
MEDTRONIC SOFAMOR DANEK USA, INC.FDA reg. 1030489Memphis, TN, United StatesSpecification developer
MEDTRONIC SOFAMOR DANEK USA, INC.FDA reg. 3003120897Memphis, TN, United StatesManufacturer
MEDTRONIC XOMED, INC.FDA reg. 1045254Jacksonville, FL, United StatesManufacturer
OSTEOTECH, INC.FDA reg. 2249915EATONTOWN, NJ, United StatesManufacturer
WARSAW ORTHOPEDIC, INC.FDA reg. 1824199WARSAW, IN, United StatesManufacturer

Other names on FDA records

Medtronic Sofamor Danek Usa, Inc. · Medtronic Xomed Inc · Osteotech, Inc. · Medtronic Neurosurgery · Medtronic Sofamor Danek Deggendorf GmbH · Warsaw Orthopedic, Inc. · Medtronic Engineering and Innovation Center (MEIC)

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2112641). 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.