Dental Device Guide
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Manufacturer registered with FDA

Stryker

Kalamazoo, MI, United States. Lists 14 dental device types with FDA across 8 registered establishments, and holds 33 510(k) clearances as applicant.

FDA owner/operator1811755Contract manufacturerForeign exporterManufacturerSpecification developer4 clearances in five years
Device types listed
14
Brands and models
67
510(k) clearances
331987–2024
Markets registered in
142,700 registrations outside the US
Establishments
8Germany, Ireland, United States
1987: 11994: 21996: 11999: 12000: 22002: 22003: 22004: 12005: 12012: 12013: 22014: 42015: 12017: 32018: 12019: 22020: 22022: 12023: 22024: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 14 markets

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

All markets
United States: 14 device types listedCanada: 793 registrationsSouth Korea: 432 registrationsEuropean Union: 423 registrationsTaiwan: 260 registrationsSaudi Arabia: 171 registrationsBrazil: 144 registrationsAustralia: 143 registrationsUnited Kingdom: 117 registrationsColombia: 68 registrationsIsrael: 66 registrationsPeru: 56 registrationsHong Kong: 16 registrationsChina: 11 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerStryker33 clearances1987–2024Below
CanadaHealth CanadaRegistration holderSTRYKER LEIBINGER GMBH & CO. KG7931998–2026Pure Global AI
South KoreaMFDSManufacturerStryker Leibinger GmbH & Co.KGStryker Leibinger GmbH & Co. KG · Stryker Manufacturing Kalamazoo · +24321998–2026Pure Global AI
European UnionEUDAMEDRegistration holderStryker GmbHStryker Instruments · Stryker Leibinger GmbH & Co.KG · +1423—Pure Global AI
TaiwanTFDAManufacturerSTRYKER ENDOSCOPYSTRYKER INSTRUMENTS · STRYKER LEIBINGER GMBH & CO.KG · +22601987–2026Pure Global AI
Saudi ArabiaSFDAManufacturerStryker Leibinger GmbH & Co.KGStryker Leibinger GmbH & Co. KG171—Pure Global AI
BrazilANVISAManufacturerSTRYKER ENDOSCOPYSTRYKER LEIBINGER GMBH & CO. KG · STRYKER INSTRUMENTS · +21442000–2026Pure Global AI
AustraliaTGAManufacturerStryker Leibinger GmbH & Co KG1432004–2026Pure Global AI
United KingdomMHRAManufacturerStryker Leibinger GmbH & Co. KG117—Pure Global AI
ColombiaINVIMAManufacturerSTRYKER LEIBINGER GMBH & CO. KGSTRYKER ENDOSCOPY · STRYKER CORPORATION · +268—Pure Global AI
IsraelAMARManufacturerStryker EndoscopyStryker Instruments · Stryker Leibinger GmbH & Co. KG · +166—Pure Global AI
PeruDIGEMIDManufacturerSTRYKER ENDOSCOPYSTRYKER INSTRUMENTS562013–2025Pure Global AI
Hong KongMDDManufacturerStryker Leibinger GmbH & Co. KGStryker leibinger GmbH & Co. KG162020–2026Pure Global AI
ChinaNMPARegistration holder德国史赛克莱宾格股份两合公司Stryker Leibinger GmbH & Co. KG德国史赛克莱宾格股份两合公司Stryker Leibinger GmbH & Co.KG · 德国史赛克莱宾格股份两合公司 Stryker Leibinger GmbH & Co.KG11—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 Stryker 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
add nameBurr Hole coversCustom Mandible Recon PlateDelta DualStartDelta Resorbable Fixation SystemDelta SystemDualStartK-WIRE 1X160mm (PACK OF 10)MEDPOR TITAN 3D Orbital Floor ImplantMicro Dynamic Mesh
18 more
MP LeFort I PlatesMRI UniversalNewGen/Universal Mandibular SystemPLATESteinhauser Titanium mini bone plates and screwsStryker Customized Mandible Recon PlateStryker Customized Mandible Recon Plate KitStryker Facial iD Plating SystemStryker Leibinger Universal Neuro SystemStryker Resorbable Fixation SystemStryker Surgeon iD Mandible Recon PlateStryker Surgeon iD Mandible Recon Plate (SMRP)Stryker Universal Orbital Floor SystemStryker Universal SMARTLock Hybrid MMF SystemStryker Upper-Face AXS screws and Mid-Face AXS screwsUniversal CMF SystemUniversal MeshUniversal Mesh - Sterile
1997
Manual Wire Driver and Bone DrillDZJ · Class 2Surgical drills & motorsMaker
CORE SystemDelta SystemPi Drive 2 MotorPi Drive 2 Plus MotorSTRYKER DRILLStryker Resorbable Fixation SystemTotal Performance System (TPS)
2006
Powered Bone DrillDZI · Class 2Surgical drills & motorsMaker
TPS ConsoleTPS Micro Drill/Elite Attachment BrushTPS Standard Attachment BrushTPS Unidirectional Footswitch
2007
Intraosseous Fixation ScrewDZL · Class 2Maxillofacial plates & screwsMaker
add nameDelta DualStartDelta Resorbable Fixation SystemDelta SystemDualStartMRI UniversalStryker MMF ScrewsStryker Resorbable Fixation SystemStryker Universal SMARTLock Hybrid MMF System
2008
Operative Dental UnitEIA · Class 1Dental chairs & operative unitsMaker
TPS ConsoleTPS Micro Drill/Elite Attachment BrushTPS Standard Attachment BrushTPS Unidirectional Footswitch
2007
Dental BurEJL · Class 1Dental burs & diamondsMaker—1992
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
add nameLeibinger IMF ScrewsStryker Leibinger Skeletal Anchorage System
2008
Implant Temporomandibular JointLZD · Class 3—Maker
TMJ Concepts
2021
External Mandibular Fixator and/or DistractorMQN · Class 2Maxillofacial plates & screwsMaker
MANDIBULAR BONE DISTRACTOR IIPMDPMD 2Stryker Pediatric Mandibular DistractorStryker Pediatric Mandibular Distractor 2
2008
Intraoral Synthetic BarrierNPK · Class 2Bone grafts & membranesLister
MEDPOR CONTAIN CAN ImplantMEDPOR CONTAIN Implant
2010
Surgical Headlight LightEBA · Class 1Dental operating lightsMaker
DENTAL HEADLIGHT
1992
Preformed BarEHO · Class 1—Maker
Archbar
2010
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Hybrid MMF Spacer
2017
Temporary Mandibular Condyle ProsthesisNEI · Class 2—Maker
Stryker Temporary Condylar Prosthesis
2014

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 Stryker as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
12 Jul 2024K240651MRI UniversalJEY Bone Plate
24 Aug 2023K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL Intraosseous Fixation Screw
5 Aug 2023K230733Stryker Resorbable Fixation SystemJEY Bone Plate
9 Nov 2022K221855Universal CMF SystemJEY Bone Plate
26 Mar 2020K193143Stryker Facial iD Plating SystemJEY Bone Plate
26 Mar 2020K193136Stryker Customized Mandible Recon Plate KitJEY Bone Plate
28 Jun 2019K190696Stryker Surgeon iD Mandible Recon PlateJEY Bone Plate
7 Jan 2019K182305Stryker Facial iD Plating SystemJEY Bone Plate
11 Sep 2018K181504Stryker Pediatric Mandibular Distractor 2MQN External Mandibular Fixator and/or Distractor
8 Nov 2017K170773Stryker Universal MeshJEY Bone Plate
31 Oct 2017K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsJEY Bone Plate
24 Jul 2017K171364MP LeFort I PlatesJEY Bone Plate
5 May 2015K142568Stryker MEDPOR TITAN 3D Orbital Floor ImplantJEY Bone Plate
1 Aug 2014K133461STRYKER UNIVERSAL ORBITAL FLOOR SYSTEMJEY Bone Plate
9 Apr 2014K133285STRYKER TEMPORARY CONDYLAR PROSTHESISNEI Temporary Mandibular Condyle Prosthesis
20 Mar 2014K133398STRYKER PEDIATRIC MANDIBLE DISTRACTORMQN External Mandibular Fixator and/or Distractor
9 Jan 2014K121235LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMJEY Bone Plate
6 Dec 2013K132519STRYKER CUSTOMIZED MANDIBLE RECON PLATE KITJEY Bone Plate
9 Apr 2013K123786STRYKER UNIVERSAL ORBITAL FLOOR SYSTEMJEY Bone Plate
31 Oct 2012K122313STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEMJEY Bone Plate
17 Mar 2005K050535STRYKER MMF SCREWDZL Intraosseous Fixation Screw
1 Apr 2004K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMDZJ Manual Wire Driver and Bone Drill
10 Sep 2003K031659UNIVERSAL NEURO SYSTEMJEY Bone Plate
8 Aug 2003K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEMDZI Powered Bone Drill
17 Dec 2002K022185UNIVERSAL CMF SYSTEMJEY Bone Plate
8 Mar 2002K014263NEWGEN/UNIVERSAL MANDIBULAR SYSTEMJEY Bone Plate
12 Dec 2000K003660LEIBINGER NEURO CLIP SYSTEMJEY Bone Plate
16 Nov 2000K002619NEWGEN SYSTEMJEY Bone Plate
25 Oct 1999K991696STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEMDZI Powered Bone Drill
20 Aug 1996K954690STRYKER ORAL MAX SYSTEMDZI Powered Bone Drill
30 Nov 1994K943540SURGICAL CUTTING BURSDZJ Manual Wire Driver and Bone Drill
10 Mar 1994K921805STRYKER PRECISION DENTAL IMPLANT SYSTEMDZE Root-Form Endosseous Implant
3 Aug 1987K871816STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TMEAY Dental Fiber Optic Light

Some of these clearances are listed with FDA today by another company: Bicon, LLC (1).

Also lists devices cleared under other names

Stryker 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: Howmedica Corp. (3), Porex Surgical, Inc. (2), W&H Dentalwerk Bürmoos GmbH (1), Stryker Craniomaxillofacial (1), Stryker Craniomaxillofacial (Cmf) (1), Stryker Leibinger Micro Implants (1), Stryker Leibinger (1), Howmedica Leibinger, Inc. (1).

Decided510(k)DeviceApplicantDevice type
31 Jul 2026K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHDZI Powered Bone Drill
13 Jan 2024K232350Stryker Facial iD SystemStryker CraniomaxillofacialJEY Bone Plate
9 Dec 2022K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)JEY Bone Plate
4 Feb 2022K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro ImplantsJEY Bone Plate
7 Jan 2011K102184MEDPOR CONTAIN CAN IMPLANTPorex Surgical, Inc.NPK Intraoral Synthetic Barrier
19 Mar 2010K091120MEDPOR CONTAIN IMPLANTPorex Surgical, Inc.NPK Intraoral Synthetic Barrier
30 Sep 2004K041651STRYKER LEIBINGER SKELETAL ANCHORING SYSTEMStryker LeibingerDZE Root-Form Endosseous Implant
29 Jan 1999K983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESHowmedica Corp.JEY Bone Plate
23 Dec 1998K983528MICRO DYNAMIC MESHHowmedica Corp.JEY Bone Plate
11 Apr 1997K963030LEIBINGER IMF SCREWHowmedica Leibinger, Inc.DZE Root-Form Endosseous Implant
6 Aug 1996K960297MANDIBULAR BONE DISTRACTOR IIHowmedica Corp.MQN External Mandibular Fixator and/or Distractor
25 Jul 1986K862482STEINHAUSER TITANIUM MINI BONE PLATES & SCREWSWalter Lorenz Surgical, Inc.JEY Bone Plate

Registered establishments

EstablishmentLocationWhat it does
STRYKER ENDOSCOPYFDA reg. 2936485SAN JOSE, CA, United StatesManufacturer
Stryker InstrumentsFDA reg. 3015967359Portage, MI, United StatesComplaint file establishment, Specification developer
Stryker Ireland Ltd. Instruments Division, Innovation CentreFDA reg. 3040335671Carrigtwohill Cork(County), IrelandSpecification developer
STRYKER IRELAND LTD., INSTRUMENTS DIVISIONFDA reg. 9616696CARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer
STRYKER LEIBINGER GMBH & CO. KGFDA reg. 8010177FREIBURG Baden-Wurttemberg, GermanyComplaint file establishment, Foreign exporter, Manufacturer, Specification developer
STRYKER MANUFACTURING KALAMAZOOFDA reg. 3007997036Portage, MI, United StatesContract manufacturer
STRYKER PUERTO RICO, LLC.FDA reg. 2648666ARROYO, PR, United StatesManufacturer
TMJ Solutions, LLCFDA reg. 2031049San Buenaventura, CA, United StatesContract manufacturer

Other names on FDA records

Stryker Instruments · Stryker Leibinger GmbH & Co. KG · Stryker Endoscopy · Stryker Ireland Ltd. Instruments Division · Stryker Manufacturing Kalamazoo · Stryker Puerto Rico, LLC. · TMJ Solutions Inc. · Stryker Ireland Ltd. Instruments Division, Innovation Centre

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1811755). 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.