Manufacturer registered with FDA
STERIS Corporation
Mentor, OH, United States. Lists 70 dental device types with FDA across 31 registered establishments.
- Device types listed
- 70
- Brands and models
- 113
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8195 registrations outside the US
- Establishments
- 31Switzerland, Germany, France +6
Registered in 8 markets
Where regulators' registries name STERIS 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 | STERIS Corporation | 70 device types | — | Below |
| Taiwan | TFDA | Manufacturer | STERIS CORPORATIONSTERIS Corporation · STERIS SAS · +2 | 98 | 2005–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | STERIS Corporation | 52 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | STERIS CORPORATIONSTERIS SAS | 25 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | STERIS CORPORATIONSTERIS SAS | 10 | 2011–2020 | Pure Global AI |
| Israel | AMAR | Manufacturer | STERIS CorporationSteris Corporation · STERIS · +1 | 7 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | STERIS CORPORATION | 2 | 2015–2019 | Pure Global AI |
| South Korea | MFDS | Manufacturer | STERIS Laboratories | 1 | 2021–2021 | 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 STERIS 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Accumedix377 (LS) - Blue Sky Bio Dental Implant System - Internal Octagon Taper; Blue Sky Bio Dental Implant SystemAccumedix3772 (LS) - Blue Sky BioAccumedix3772 (LS) - Blue Sky Bio Dental Implant SystemAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / ConusAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Double Hex 3 PlatformAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Internal Hex; Blue Sky Bio Dental Implant System - Tri-LobeAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Octagon Regular and Wide ShortAccumedix3772 (LS) - Blue Sky Bio Pterygoid Implants and AbutmentsAmericanDentImp4284 (WH) - Dental ImplantAmericanDentImp4284 (WH) - Implant, Endosseous, Root-Form 32 moreBasicDental5438 (EP1) - Dental ImplantBiconDental1716 (NR) - 3mm Narrow Bicon Implant SystemBiconDental1716 (NR) - 4.5 x 6mm and 6 x 6mm Dental ImplantBiconDental1716 (NR) - 4.5mm ImplantsBiconDental1716 (NR) - 5 x 6mm Dental ImplantBiconDental1716 (NR) - 5mm SHORT ImplantsBiconDental1716 (NR) - 6 x 5.7mm Implant SystemBiconDental1716 (NR) - 6 x 8mm ImplantBiconDental1716 (NR) - Integra-Ti, Integra-CP, Bicon ImplantBiconDental1716 (NR) - MAX 2.5 Implant SystemBiconDental1716 (NR) - NanoTite Surface TreatmentBiconDental1716 (NR) - Original Bicon Dental Implant SystemBiconDental1716 (NR) - Original Temporary Implant SystemBiconDental1716 (NR) - Orthodontic Implant SystemBiomet3824 (LS) - Titanium Hexed ScrewDOT (RB) - Surgikor Dental Implant SystemNobel6405 (NT) - Snappy AbutmentOcoBiomed2873 (EP1) - 3 Dental ImplantOcoBiomed2873 (EP1) - Engage / Engage PlusOcoBiomed2873 (EP1) - Immediate Stabilizing Implant (ISI)OcoBiomed2873 (EP1) - Small Diameter Implant (SDI)OcoBiomed2873 (EP1) - TSI / ERIQTS3938 (LS) - Thread ImplantStraumann5915 (NR) - NNC Closure screw, H0Straumann5915 (NR) - NNC Closure screw, H1.5Thommen12483 (DK) - ELEMENT PF 3Thommen12483 (DK) - SPI Contact PF 4Thommen12483 (DK) - SPI ELEMENT INICELL, SPI CONTACT INICELLThommen12483 (DK) - SPI ELEMENT, SPI CONTACT, SPI ONETIME, SPI DIRECTThommen12483 (DK) - SPI System Dental ImplantsZimmerDental9690 (RG) - Zimmer Dental - Spline Twist ImplantZimmerDental9690 (RG) - Zimmer Dental - SwissPlus Implant System | 2012 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | Accumedix3772 (LS) - Blue Sky BioAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / ConusAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Double Hex 3 PlatformAccumedix3772 (LS) - Blue Sky Bio Dental Implant System - Octagon Regular and Wide ShortAccumedix3772 (LS) - Blue Sky Bio Pterygoid Implants and AbutmentsBiconDental1716 (NR) - MAX 2.5 Implant SystemDOT (RB) - Surgikor Dental Implant SystemEuroteknika14350 (MS) - iphysio® Profile DesignerNobel6405 (NT) - Snappy AbutmentThommen12483 (DK) - ELEMENT PF 3 4 moreThommen12483 (DK) - SPI Contact PF 4Thommen12483 (DK) - SPI VARIO, SPI VARIO T, SPI Temporary, SPI EASY, SPI RETAINZimmerDental9690 (RG) - Hex-Lock Short AbutmentZimmerDental9690 (RG) - Prepared Hex-Lock Abutment | 2012 |
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | — | 2012 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | ATRISORB®-D Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% DoxycyclineBiconDental1716 (NR) - SynthoGraftMedtronicSofamore (AH) - BIPHASIC CALCIUM BOOsteogene8842 (WH) - InRoad Dental Synthetic Bone GraftTeknimed11593 (MS) - Osteofast Dental | 2012 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | — | 2012 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Lister | Synthes8894 (DK) - POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSSynthes8894 (DK) -POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSUnicareBiomed3455 (NT) Cytoflex mesh | 2012 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | FKG8620 (BF) - EDGE EVOLVEFKG8620 (BF) - EDGE ONE PLATINUMFKG8620 (BF) - EDGE SEQUEL SAPPHIREFKG8620 (BF) - EDGE TAPER RETREATFKG8620 (BF) - EDGE V-TAPERFKG8620 (BF) - EDGE V-TAPER GLIDEPATHFKG8620 (BF) - EDGEDIAMOND UTOPIAFKG8620 (BF) - EDGEFILE X3FKG8620 (BF) - EDGEFILE X7FKG8620 (BF) - EdgeGlidepath 20 moreFKG8620 (BF) - EdgeOne FireFKG8620 (BF) - EdgeOne GlidepathFKG8620 (BF) - EdgeTaperFKG8620 (BF) - EdgeTaper PlatinumFKG8620 (BF) - PROMO SETSFKG8620 (BF) - X1FKG8620 (BF) - XP-4DFKG8620 (BF) - XRFKG8620 (DK, BF*) - BT-RACEFKG8620 (DK, BF*) - CM NITI FILESFKG8620 (DK, BF*) - CM TAPER FILESFKG8620 (DK, BF*) - EDGE SEQUEL UTOPIAFKG8620 (DK, BF*) - EDGE X7 UTOPIAFKG8620 (DK, BF*) - ESXFKG8620 (DK, BF*) - ORIFICE SHAPERFKG8620 (DK, BF*) - RECIPROCATING CMFKG8620 (DK, BF*) - SCOUTFKG8620 (DK, BF*) - XP-3D + PROKITFKG8620 (DK, BF*) - XP-3D FINISHERFKG8620 (DK, BF*) - XP-3D SHAPER + | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | — | 2013 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | — | 2012 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | — | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | WhiteBurr3283 (WH,CH1) - SS White Carbide Burs | 2012 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Lister | — | 2017 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Lister | — | 2022 |
| Dental Prophylaxis KitNYC · Class 1 | Dental hand instruments | Lister | — | 2013 |
| Oral Surgery TrayPWL · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | V. Mueller Endontia Rongeur (ST-CFE) | 2018 |
| Denture Repair KitEBO · Class 2 | — | Lister | — | 2013 |
| Roll CottonEFN · Class 1 | — | Lister | — | 2019 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | WhiteBurr3283 (WP, CH1) - Jazz Polisher | 2023 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | — | 2017 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | V. Mueller Open Retractors (ST-CFE) | 2020 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | — | 2013 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | — | 2013 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | Acuderm1463 (WH,LS) - Acu-Punch | 2012 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | V. Mueller Oral Extracting Forceps (ST-CFE) | 2020 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | V. Mueller Bone File (ST-CFE)V. Mueller Bone File Bayonet (WM-RR) | 2024 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | V. Mueller Oral Elevators (ST-CFE) | 2020 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Snowden-Pencer Dental Currette (ST-SD, WM-FE, RR) | 2024 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | Snowden-Pencer Osteotome Chisel (WM-FE,RR)V. Mueller Osteotome Chisel (ST-SD) | 2024 |
| Nose and Throat Ear CementNEA · Class 2 | — | Lister | — | 2023 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Lister | — | 2013 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Lister | — | 2013 |
| Dental Hygiene KitNXZ · Class 1 | — | Lister | — | 2013 |
| Endodontic KitNYD · Class 2 | — | Lister | — | 2013 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Lister | — | 2013 |
| Gingival Retraction KitNYF · Class 1 | Dental hand instruments | Lister | — | 2013 |
| Lapping Tool KitNYG · Class 1 | Dental hand instruments | Lister | — | 2013 |
| Plaque Disclosing KitNYH · Class 2 | — | Lister | — | 2013 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | Accumedix3772 (LS) - Blue Sky Bio TADLSO2556 (NT) - Ormco VectorTAS Mini Screw | 2020 |
| Restorative Instrument and Component TrayOFW · Class 2 | — | Lister | — | 2013 |
| General Purpose Dental TrayOFX · Class 1 | — | Lister | — | 2013 |
| Dental Implant Surgical TrayOFY · Class 1 | Implant instruments & surgical kits | Lister | — | 2013 |
| Oral Irrigation KitOGT · Class 1 | — | Lister | — | 2013 |
| Intraoral Wire Lock and LigatureDYX · Class 2 | — | Lister | — | 2024 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | — | 2016 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Lister | — | 2026 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | — | 2023 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | — | 2020 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Lister | — | 2020 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Lister | — | 2023 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Lister | V. Mueller Tissue Forceps (WM-FE,RR) | 2024 |
| Preformed BarEHO · Class 1 | — | Lister | V. Mueller Dental Arch Bar (ST-CFE) | 2025 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Lister | — | 2019 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | — | 2017 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Lister | — | 2013 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | — | 2020 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Lister | — | 2020 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Medivance9720 (RG) - BAG 45S5 | 2026 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Lister | — | 2020 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | — | 2022 |
| Preformed CrownELZ · Class 1 | — | Lister | — | 2019 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | — | 2020 |
| AirbrushKOJ · Class 2 | — | Lister | Medivance9720 (RG) - Aquacut Quattro AquaCare Twin, AquaCare Single | 2026 |
| Implant Temporomandibular JointLZD · Class 3 | — | Lister | Zimmer (LN) - Total Temporomandibular Joint Replacement System | 2026 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Lister | — | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Isomedix Operations IncFDA reg. 3009888344 | El Paso, TX, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INCFDA reg. 1643817 | EL PASO, TX, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INCFDA reg. 1526711 | GROVEPORT, OH, United States | Contract sterilizer |
| Isomedix Operations Inc.FDA reg. 2032112 | SAN DIEGO, CA, United States | Contract sterilizer |
| Isomedix Operations Inc.FDA reg. 2246552 | S Plainfield, NJ, United States | Contract sterilizer |
| Isomedix Operations Inc.FDA reg. 3013820501 | Chester, NY, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INC.FDA reg. 2245304 | WHIPPANY, NJ, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INC.FDA reg. 1319660 | CHESTER, NY, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INC.FDA reg. 1220477 | Northborough, MA, United States | Contract sterilizer |
| ISOMEDIX OPERATIONS INC.FDA reg. 1047843 | SPARTANBURG, SC, United States | Contract sterilizer, Manufacturer for export |
| Isomedix Operations, IncFDA reg. 2032098 | ONTARIO, CA, United States | Contract sterilizer |
| Isomedix Operations, Inc.FDA reg. 1450662 | Libertyville, IL, United States | Contract sterilizer |
| Isomedix Operations, Inc.FDA reg. 1424263 | Libertyville, IL, United States | Contract sterilizer |
| Isomedix Operations, Inc.FDA reg. 2183744 | Minneapolis, MN, United States | Contract sterilizer |
| STERIS CorporationFDA reg. 1923569 | Saint Louis, MO, United States | Complaint file establishment, Specification developer |
| STERIS Deutschland GmBhFDA reg. 3006554912 | Wurmlingen Baden-Wurttemberg, Germany | Foreign exporter, Repacker / relabeler |
| STERIS LaboratoriesFDA reg. 2183828 | Brooklyn Park, MN, United States | Contract sterilizer |
| STERIS Schweiz AGFDA reg. 8043792 | Daniken Solothurn, Switzerland | Contract sterilizer |
| STERIS SPAFDA reg. 3002806603 | CALCINATE Bergamo, Italy | Contract sterilizer |
| Synergy Health Allershausen GmbHFDA reg. 3010160527 | Allershausen Bavaria, Germany | Contract sterilizer |
| Synergy Health Ede BVFDA reg. 3009756327 | Ede Gelderland, Netherlands | Contract sterilizer |
| Synergy Health Ireland LtdFDA reg. 3002807314 | Tullamore Offaly, Ireland | Contract sterilizer |
| Synergy Health Marseille SASFDA reg. 3010162973 | MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, France | Contract sterilizer |
| Synergy Health Marseille SASFDA reg. 3010897183 | CHUSCLAN Gard, France | Contract sterilizer |
| Synergy Health Radeberg GMBHFDA reg. 3008102042 | Radeberg Saxony, Germany | Contract sterilizer |
| Synergy Health Sterilisation UK LtdFDA reg. 3010155661 | Thorne Doncaster, United Kingdom | Contract sterilizer |
| Synergy Health Sterilisation UK LtdFDA reg. 3002807310 | Berkshire Reading, United Kingdom | Contract sterilizer |
| Synergy Health Sterilisation UK LtdFDA reg. 3010155648 | West Yorkshire Bradford, United Kingdom | Contract sterilizer |
| SYNERGY HEALTH STERILISATION UK LTDFDA reg. 3002807315 | Daventry Northamptonshire, United Kingdom | Contract sterilizer |
| Synergy Health Westport LtdFDA reg. 3010173425 | Westport Mayo, Ireland | Contract sterilizer |
| Synergy Sterilisation South Africa Proprietary LtdFDA reg. 3010287685 | Isando Gauteng, South Africa | Contract sterilizer |
Other names on FDA records
STERIS Laboratories · Synergy Sterilisation South Africa Proprietary Ltd · Synergy Health Sterilisation UK Ltd · STERIS Schweiz AG · Synergy Health Marseille SAS · Synergy Health Ede BV · Synergy Health Allershausen GmbH · Synergy Health Ireland Ltd · Synergy Health Radeberg GMBH · Synergy Health Westport Ltd · Isomedix Operations Inc. · STERIS Deutschland GmBh
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042227, 1527821, 10091086, 9072619). 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.