Manufacturer registered with FDA
Integra LifeSciences Corporation
Princeton, NJ, United States. Lists 74 dental device types with FDA across 8 registered establishments, and holds 2 510(k) clearances as applicant.
- Device types listed
- 74
- Brands and models
- 207
- 510(k) clearances
- 21999–2014
- Markets registered in
- 111,877 registrations outside the US
- Establishments
- 8Canada, Germany, United States
510(k) clearances per year, 1990–2026
Registered in 11 markets
Where regulators' registries name Integra LifeSciences Corporation as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Integra LifeSciences Corporation | 2 clearances | 1999–2014 | Below |
| Canada | Health Canada | Registration holder | INTEGRA LIFESCIENCES PRODUCTION CORPORATIONINTEGRA LIFESCIENCES CORPORATION · INTEGRA PAIN MANAGEMENT | 1,057 | 1998–2024 | Pure Global AI |
| Australia | TGA | Registration holder | Integra Neurosciences Pty Ltd | 222 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jarit GmbHIntegra NeuroSciences · Integra Neurosciences · +2 | 212 | 1998–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INTEGRA LIFESCIENCES PRODUCTION CORPORATIONINTEGRA LIFESCIENCES CORPORATION | 126 | 2007–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Integra LifeSciences Production CorporationINTEGRA LIFESCIENCES CORPORATION · Integra LifeSciences Corporation · +2 | 86 | 1996–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | INTEGRA LIFESCIENCES CORPORATIONINTEGRA LIFESCIENCES PRODUCTION CORPORATION · INTEGRA NEUROSCIENCES LTD. · +2 | 76 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Integra LifeSciences Production CorporationIntegra LifeSciences Corporation · Integra Lifesciences Corp. · +2 | 36 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | Integra LifeSciences CorporationIntegra LifeSciences Production Corporation · Integra Lifesciences Corporation | 31 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | INTEGRA LIFESCIENCES PRODUCTION CORPORATIONINTEGRA LIFESCIENCES CORPORATION · INTEGRA LIFE SCIENCES CORPORATION | 27 | 2016–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | INTEGRA NEUROSCIENCESIntegra NeuroSciences, Ltd. · Integra Pain Management | 4 | — | 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 Integra LifeSciences Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | BioMend Absorbable Collagen MembraneBiomend Extend Absorbable Collagen MembraneHeliMend Absorbable Collagen MembraneHeliMend Advanced Absorbable Collagen MembraneOraMem Absorbable Collagen MembraneOraMem Sustained Absorbable Collagen Membrane | 2007 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | IntegraJaritMiltex | 2009 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | IntegraJaritMicroFranceMiltexPadgett | 1981 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | JaritMiltex | 1981 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 1981 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | Carb-N-SertIntegraIntegra JaritIntegra MiltexJaritMiltexPadgett | 2001 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 1981 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | Ceram-A-GripGrip DeepJaritMiltexPadgettXcision | 1981 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | IntegraJaritMicroFranceMiltex | 1981 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | IntegraJaritMiltex | 1981 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | IntegraMicroFranceMiltex | 1992 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | IntegraJaritMiltex | 1981 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | IntegraJaritMiltex | 1981 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | IntegraMiltex | 2001 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | IntegraJaritMiltexPadgettTactile ToneThompson | 1981 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 1992 |
| Collar and Crown ScissorsEIR · Class 1 | Dental hand instruments | Maker | IntegraIntegra MiltexJaritMiltex | 1981 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 1981 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | GripLiteJaritMiltexRMH IntegratorSilitoneTactile Tone | 2008 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | IntegraIntegra MiltexMiltex | 2001 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | IntegraIntegra MiltexMiltex | 2003 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | IntegraJaritMiltex | 1981 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | IntegraIntegra JaritIntegra MiltexJaritMiltexPadgett | 1981 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Maker | Miltex | 1981 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | JaritMiltexPadgett | 2008 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | IntegraJaritMiltex | 2001 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | JaritMiltexPadgett | 2001 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | MiltexPadgett | 1992 |
| Shellac Base PlateEEA · Class 1 | — | Maker | MiltexPadgett | 2001 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | MiltexPadgett | 2001 |
| Articulation PaperEFH · Class 1 | — | Maker | ArticodentMiltex | 1996 |
| Roll CottonEFN · Class 1 | — | Maker | MiltexPadgett | 2003 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Beauty PinkMiltexPadgett | 2001 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | MiltexPadgettTardie | 2008 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | IntegraMiltex | 2008 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | EvenWetLightningMiltexSpectra ASpectra F | 2001 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Miltex | 1992 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Miltex | 2010 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 2008 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | IntegraMiltex | 2001 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | IntegraJaritMiltex | 1981 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Miltex | 2001 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Miltex | 2001 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | MiltexTactile Tone | 2006 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | IntegraJaritMiltex | 1981 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | IntegraJaritMiltex | 1981 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | MiltexTactile Tone | 2006 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Lister | IntegraJaritMiltex | 2006 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | MiltexTactile Tone | 1981 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | JaritMiltexPadgett | 2008 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | MiltexOnyx-FlexOnyx-HOnyx-RTactile Tone | 1992 |
| Endodontic Silver PointEKL · Class 1 | — | Maker | Miltex | 2001 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Inject-R-FillIntegra MiltexMiltexPrecisePrecision | 1994 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | IntegraMiltex | 1992 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | IntegraMiltex | 1992 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Flex-RHi-5LiberatorMiltexMor-FlexMoyco | 1992 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Maker | Miltex | 2001 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | MiltexTactile Tone | 2006 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | MiltexTri-R Post | 1997 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | IntegraMicroFranceMiltex | 1981 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | IntegraMicroFranceMiltexTactile Tone | 1981 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | IntegraMiltex | 1981 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | IntegraMicroFranceMiltex | 1981 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | IntegraMiltex | 1981 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | IntegraMiltex | 1981 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | MiltexTactile Tone | 2006 |
| Intraoral Wire Lock and LigatureDYX · Class 2 | — | Lister | IntegraJaritMiltexPadgettPadgett by Miltex | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | IntegraMiltexPadgettTri-R Post | 1997 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | MiltexPadgett | 1992 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Miltex | 2016 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Miltex | 2002 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | Miltex | 1992 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | Miltex | 2001 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | — | 2020 |
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 Integra LifeSciences Corporation as the applicant, including filings under its other names.
Also lists devices cleared under other names
Integra LifeSciences Corporation 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: Miltex, Inc. (1), Nakamura Magnifier Co., Ltd. (1), KLS Martin SE & Co. KG (1), Nsk Nakanishi, Inc. (1), Colla-Tec, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 9 Mar 2009 | K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Miltex, Inc. | EJI Cartridge Syringe |
| 20 Mar 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 30 Jun 2006 | K061271 | ERCH ARCH BAR, MODEL 38-690-00 | KLS Martin SE & Co. KG | DYX Intraoral Wire Lock and Ligature |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 22 Aug 1995 | K924408 | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE | Colla-Tec, Inc. | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Integra Canada ULCFDA reg. 3012507533 | Oakville Ontario, Canada | Foreign exporter |
| Integra LifeSciences CorporationFDA reg. 3003418325 | Princeton, NJ, United States | Complaint file establishment, Specification developer |
| INTEGRA LIFESCIENCES CORPORATIONFDA reg. 1121308 | PLAINSBORO, NJ, United States | Manufacturer |
| INTEGRA LIFESCIENCES CORPORATIONFDA reg. 3004608878 | CINCINNATI, OH, United States | Repacker / relabeler |
| Integra LifeSciences Production CorporationFDA reg. 3014334038 | Mansfield, MA, United States | Contract manufacturer, Manufacturer, Specification developer |
| INTEGRA NEUROSCIENCESFDA reg. 2648988 | ANASCO, PR, United States | Manufacturer |
| Integra Pain ManagementFDA reg. 1722447 | West Valley City, UT, United States | Repacker / relabeler |
| Jarit GmbHFDA reg. 3005809810 | Rietheim-Weilheim Baden-Wurttemberg, Germany | Repacker / relabeler |
Other names on FDA records
Integra NeuroSciences · Integra LifeSciences Production Corporation · Integra Pain Management · Jarit GmbH · Integra Canada ULC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9004007). 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.