Manufacturer registered with FDA

Sotera Health LLC

Oak Brook, IL, United States. Lists 61 dental device types with FDA across 29 registered establishments.

FDA owner/operator10029425Contract manufacturerContract sterilizer

Device types listed: 61
Brands and models: 994
510(k) clearances: 0as applicant
Markets registered in: 37 registrations outside the US
Establishments: 29Belgium, Brazil, Denmark +5

Registered in 3 markets

Where regulators' registries name Sotera Health LLC 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	Sotera Health LLC	61 device types	—	Below
Thailand	Thai FDA	Manufacturer	Sterigenics	4	—	Pure Global AI
Colombia	INVIMA	Manufacturer	STERIGENICS US LLC	3	—	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 Sotera Health LLC 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	Maker	Atlas Implant PacksCelsite® Discreet STL201HCERTAIN® FLAT IMPLANT COVER SCREWCERTAIN® IMPLANT HEADLESS COVER SCREWCERTAIN® LOCATOR® ABUTMENTCERTAIN® MICROMINI FLAT IMPLANT COVER SCREWCover Screw HeadlessDental implants BT-Tite CV2 (BTICV2)Dental implants BT-Tite CV3 (BTICV3)Dental implants BT-Tite One (BTICV1) and abutments 296 more Dental implants BT-Tite Standard (BTIVSM)Dental Implants Inclusive Tapered Dental ImplantsEK Cover ScrewEK D3.3 NH ImplantEK D3.3 SA ImplantEK Healing AbutmentEK NH ImplantEK NH Ultra Wide ImplantEK SA ImplantEK SA Ultra Wide ImplantEM ProvisionalEM SA Implant SystemET Cover ScrewET Healing AbutmentET II SA FIXTURE SYSTEMET III Nano-HA Fixture SystemETIII SA Fixture SystemETIII SA Fixture System (D3.2)ETIII SA Fixture System (D3.2) implantETIV SA Dental ImplantsGlidewell HT Implant 6 x 10 mmGlidewell HT Implant 6 x 11.5 mmGlidewell HT Implant Healing Abutment 3 mmH - 6 ImplantGlidewell HT Implant Healing Abutment 5 mmH - 6 ImplantGlidewell IH Implant 3.2 mmD x 10 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 11.5 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 13 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 16 mmL x 3 mmPGlidewell IH Implant 3.7 mmD x 10 mmL x 3.5 mmPGlidewell IH Implant 3.7 mmD x 11.5 mmL x 3.5 mmPGlidewell IH Implant 3.7 mmD x 13 mmL x 3.5 mmPGlidewell IH Implant 3.7 mmD x 16 mmL x 3.5 mmPGlidewell IH Implant 4.2 mmD x 10 mmL x 3.5 mmPGlidewell IH Implant 4.2 mmD x 11.5 mmL x 3.5 mmPGlidewell IH Implant 4.2 mmD x 13 mmL x 3.5 mmPGlidewell IH Implant 4.2 mmD x 16 mmL x 3.5 mmPGlidewell IH Implant 4.2 mmD x 8 mmL x 3.5 mmPGlidewell IH Implant 4.7 mmD x 10 mmL x 4.5 mmPGlidewell IH Implant 4.7 mmD x 11.5 mmL x 4.5 mmPGlidewell IH Implant 4.7 mmD x 13 mmL x 4.5 mmPGlidewell IH Implant 4.7 mmD x 16 mmL x 4.5 mmPGlidewell IH Implant 4.7 mmD x 8 mmL x 4.5 mmPGlidewell IH Implant 5.2 mmD x 10 mmL x 4.5 mmPGlidewell IH Implant 5.2 mmD x 11.5 mmL x 4.5 mmPGlidewell IH Implant 5.2 mmD x 13 mmL x 4.5 mmPGlidewell IH Implant 5.2 mmD x 16 mmL x 4.5 mmPGlidewell IH Implant 5.2 mmD x 8 mmL x 4.5 mmPGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 7 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 7 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 3.5 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 3.5 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 3.5 mmD x 7 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 4.7 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 4.7 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3.5 mmP x 4.7 mmD x 7 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 4.5 mmD x 3 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 4.5 mmD x 5 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 4.5 mmD x 7 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 5.7 mmD x 3 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 5.7 mmD x 5 mmHGlidewell IH Implant Healing Abutment 4.5 mmP x 5.7 mmD x 7 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 1.5 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 2.5 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 3.5 mmHHahn Tapered Implant 03 x 11.5 mmHahn Tapered Implant 03 x 13 mmHahn Tapered Implant 03 x 16 mmHahn Tapered Implant 03.5 x 10 mmHahn Tapered Implant 03.5 x 11.5 mmHahn Tapered Implant 03.5 x 13 mmHahn Tapered Implant 03.5 x 16 mmHahn Tapered Implant 03.5 x 8 mmHahn Tapered Implant 04.3 x 10 mmHahn Tapered Implant 04.3 x 11.5 mmHahn Tapered Implant 04.3 x 13 mmHahn Tapered Implant 04.3 x 16 mmHahn Tapered Implant 04.3 x 8 mmHahn Tapered Implant 05 x 10 mmHahn Tapered Implant 05 x 11.5 mmHahn Tapered Implant 05 x 13 mmHahn Tapered Implant 05 x 16 mmHahn Tapered Implant 05 x 8 mmHahn Tapered Implant 07 x 10 mmHahn Tapered Implant 07 x 11.5 mmHahn Tapered Implant 07 x 8 mmHahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 17 Multi-Unit Abut. 2.5 mmH - 05 ImplantHahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 17 Multi-Unit Abut. 3.5 mmH - 05 ImplantHahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 05 ImplantHahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 05 ImplantHahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 30 Multi-Unit Abut. 3.5 mmH - 05 ImplantHahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 30 Multi-Unit Abut. 4.5 mmH - 05 ImplantHahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 05 ImplantHahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 05 ImplantHahn Tapered Implant Healing Abutment 3 mmH - 03 ImplantHahn Tapered Implant Healing Abutment 3 mmH - 03.5 ImplantHahn Tapered Implant Healing Abutment 3 mmH - 04.3 ImplantHahn Tapered Implant Healing Abutment 3 mmH - 05 ImplantHahn Tapered Implant Healing Abutment 3 mmH - 07 ImplantHahn Tapered Implant Healing Abutment 5 mmH - 03 ImplantHahn Tapered Implant Healing Abutment 5 mmH - 03.5 ImplantHahn Tapered Implant Healing Abutment 5 mmH - 04.3 ImplantHahn Tapered Implant Healing Abutment 5 mmH - 05 ImplantHahn Tapered Implant Healing Abutment 5 mmH - 07 ImplantHahn Tapered Implant Healing Abutment 7 mmH - 03 ImplantHahn Tapered Implant Healing Abutment 7 mmH - 03.5 ImplantHahn Tapered Implant Healing Abutment 7 mmH - 04.3 ImplantHahn Tapered Implant Healing Abutment 7 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abut. 1.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03 ImplantHahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abut. 2.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03 ImplantHahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abut. 3.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abut. 4.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03 ImplantHahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03 ImplantHahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 03.5/4.3 ImplantHahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 05 ImplantHahn Tapered Implant Multi-Unit Abutment 4.5 mmH - 05 ImplantImplant Cover ScrewIMPLANT ENDOSSEOUS, ROOT FORMimplant, endosseous, root-form Implantium and SuperLine	2012
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Lister	CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENTCERTAIN® EP® HEALING ABUTMENTCERTAIN® GINGHUE TM ANGLED POSTCERTAIN® GINGIHUE® ANGLED POSTCERTAIN® GINGIHUE® POSTCERTAIN® GINGIHUE® PRE-ANGLED POSTCERTAIN® PREFORMANCE® POSTCERTAIN® PREFORMANCE® PRE-ANGLED POSTCERTAIN® PREFORMANCE® TEMPORARY CYLINDER (HEXED)CERTAIN® PREFORMANCE® TEMPORARY CYLINDER (NON-HEXED) 256 more CERTAIN® STRAIGHT HEALING ABUTMENTCERTAIN® TEMPORARY HEXED CYLINDERCONICAL HEALING CAPDental Abutments Inclusive Multi-Unit AbutmentsDental implants BT-Tite CV3 (BTICV3)EK Cover ScrewEK Healing AbutmentEK NH ImplantEK SA ImplantEP® HEALING ABUTMENTET Cover ScrewET Healing AbutmentETIII SA Fixture SystemETIII SA Fixture System (D3.2)ETIII SA Fixture System (D3.2) implantGINGIHU+C4:C33E® POSTGINGIHUE® PRE-ANGLED POSTGlidewell IH Implant 17° Multi-Unit Abutment 3.5 mmP x 2 mmHGlidewell IH Implant 17° Multi-Unit Abutment 3.5 mmP x 3 mmHGlidewell IH Implant 17° Multi-Unit Abutment 4.5 mmP x 2 mmHGlidewell IH Implant 17° Multi-Unit Abutment 4.5 mmP x 3 mmHGlidewell IH Implant 17° Multi-Unit Abutment 4.5 mmP x 5 mmHGlidewell IH Implant 3.2 mmD x 10 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 11.5 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 13 mmL x 3 mmPGlidewell IH Implant 3.2 mmD x 16 mmL x 3 mmPGlidewell IH Implant 30° Multi-Unit Abutment 3.5 mmP x 3 mmHGlidewell IH Implant 30° Multi-Unit Abutment 4.5 mmP x 3 mmHGlidewell IH Implant 30° Multi-Unit Abutment 4.5 mmP x 5 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.2 mmD x 7 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 3 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 5 mmHGlidewell IH Implant Healing Abutment 3 mmP x 3.7 mmD x 7 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 1.5 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 2.5 mmHGlidewell IH Implant Multi-Unit Abutment 3 mmP x 3.5 mmHGlidewell IH Implant Multi-Unit Abutment 3.5 mmP x 2 mmHGlidewell IH Implant Multi-Unit Abutment 3.5 mmP x 3 mmHGlidewell IH Implant Multi-Unit Abutment 3.5 mmP x 5 mmHGlidewell IH Implant Multi-Unit Abutment 4.5 mmP x 1 mmHGlidewell IH Implant Multi-Unit Abutment 4.5 mmP x 2 mmHGlidewell IH Implant Multi-Unit Abutment 4.5 mmP x 3 mmHGlidewell IH Implant Multi-Unit Abutment 4.5 mmP x 5 mmHGOLD-TITE® HEXED RETAINING SCREWHEALING ABUTMENTInclusive Multi-Unit Abutment 1 mmH compatible with: Straumann Tissue Level RN synOctaInclusive Multi-Unit Abutment 1.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mmInclusive Multi-Unit Abutment 1.5 mmH compatible with: Straumann Tissue Level WN synOctaInclusive Multi-Unit Abutment 2.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mmInclusive Multi-Unit Abutment 3.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mmInclusive Multi-Unit Abutment 4.5 mmH compatible with: Dentsply Implants Ankylos C/X 3.5/4.5/5.5/7 mmInclusive Tapered Implant 17 Multi-Unit Abut. 3.5 mmP x 2 mmHInclusive Tapered Implant 17 Multi-Unit Abut. 3.5 mmP x 3 mmHInclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 2 mmHInclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 3 mmHInclusive Tapered Implant 17 Multi-Unit Abut. 4.5 mmP x 5 mmHInclusive Tapered Implant 30 Multi-Unit Abut. 3.5 mmP x 3 mmHInclusive Tapered Implant 30 Multi-Unit Abut. 4.5 mmP x 3 mmHInclusive Tapered Implant 30 Multi-Unit Abut. 4.5 mmP x 5 mmHInclusive Tapered Implant Healing Abut. 3 mmP x 3.2 mmD x 3 mmHInclusive Tapered Implant Healing Abut. 3 mmP x 3.2 mmD x 5 mmHInclusive Tapered Implant Healing Abut. 3 mmP x 3.2 mmD x 7 mmHInclusive Tapered Implant Multi-Unit Abut. 3 mmP x 1.5 mmHInclusive Tapered Implant Multi-Unit Abut. 3 mmP x 2.5 mmHInclusive Tapered Implant Multi-Unit Abut. 3 mmP x 3.5 mmHInclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 1 mmHInclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 2 mmHInclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 3 mmHInclusive Tapered Implant Multi-Unit Abut. 3.5 mmP x 5 mmHInclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 1 mmHInclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 2 mmHInclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 3 mmHInclusive Tapered Implant Multi-Unit Abut. 4.5 mmP x 5 mmHInclusive® 17 Multi-Unit Abutment, 3.5 Platform x 2 mmHInclusive® 17 Multi-Unit Abutment, 3.5 Platform x 3 mmHInclusive® 17 Multi-Unit Abutment, 4.5 Platform x 2 mmHInclusive® 17 Multi-Unit Abutment, 4.5 Platform x 3 mmHInclusive® 17 Multi-Unit Abutment, 4.5 Platform x 5 mmHInclusive® 30 Multi-Unit Abutment, 3.5 Platform x 3 mmHInclusive® 30 Multi-Unit Abutment, 4.5 Platform x 3 mmHInclusive® 30 Multi-Unit Abutment, 4.5 Platform x 5 mmHInclusive® Multi-Unit Abutment, 3.5 Platform x 1 mmHInclusive® Multi-Unit Abutment, 3.5 Platform x 2 mmHInclusive® Multi-Unit Abutment, 4.5 Platform x 1 mmHInclusive® Multi-Unit Abutment, 4.5 Platform x 2 mmHInclusive® Multi-Unit Abutment, 4.5 Platform x 3 mmHInclusive® Multi-Unit Abutment, 4.5 Platform x 5 mmHInclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 1.5 mmHInclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 2.5 mmHInclusive® Tapered Implant Multi-Unit Abutment 3 mmP x 3.5 mmHJDentalCare Dental Implant SystemJDEvolutionJDEvolution plusJDIconJDIcon plusLDA Screw NBALDA SCREW NBRLDA Screw SBLMini implantsMini Single implantsMulti-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 3.4 mmMulti-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 4.1 mmMulti-Unit Abut. 1 mmH compatible with: Biomet 3i Certain 5 mmMulti-Unit Abut. 1 mmH compatible with: Branemark System RPMulti-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 3.8 mmMulti-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 4.3 mmMulti-Unit Abut. 1 mmH compatible with: Camlog Screw-Line 5 mmMulti-Unit Abut. 1 mmH compatible with: NobelReplace NPMulti-Unit Abut. 1 mmH compatible with: NobelReplace RPMulti-Unit Abut. 1 mmH compatible with: NobelReplace WPMulti-Unit Abut. 1.5 mmH compatible with: Ankylos /XMulti-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 3.5/4Multi-Unit Abut. 1.5 mmH compatible with: Astra Tech Implant System 4.5/5Multi-Unit Abut. 1.5 mmH compatible with: Hiossen HG System MiniMulti-Unit Abut. 1.5 mmH compatible with: Hiossen HG System StandardMulti-Unit Abut. 1.5 mmH compatible with: NobelActive NPMulti-Unit Abut. 1.5 mmH compatible with: NobelActive RPMulti-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level NCMulti-Unit Abut. 1.5 mmH compatible with: Straumann Bone Level RCMulti-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 3.4 mmMulti-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 4.1 mmMulti-Unit Abut. 2 mmH compatible with: Biomet 3i Certain 5 mmMulti-Unit Abut. 2 mmH compatible with: Branemark System RPMulti-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 3.8 mmMulti-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 4.3 mmMulti-Unit Abut. 2 mmH compatible with: Camlog Screw-Line 5 mmMulti-Unit Abut. 2 mmH compatible with: MegaGen AnyRidge Implant SystemMulti-Unit Abut. 2 mmH compatible with: NobelReplace NPMulti-Unit Abut. 2 mmH compatible with: NobelReplace RPMulti-Unit Abut. 2 mmH compatible with: NobelReplace WPMulti-Unit Abut. 2.5 mmH compatible with: Ankylos /XMulti-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 3.5/4Multi-Unit Abut. 2.5 mmH compatible with: Astra Tech Implant System 4.5/5Multi-Unit Abut. 2.5 mmH compatible with: Hiossen HG System MiniMulti-Unit Abut. 2.5 mmH compatible with: Hiossen HG System StandardMulti-Unit Abut. 2.5 mmH compatible with: NobelActive NPMulti-Unit Abut. 2.5 mmH compatible with: NobelActive RPMulti-Unit Abut. 2.5 mmH compatible with: Straumann Bone Level NC	2013
Synthetic Bone Grafting MaterialLYC · Class 2	Bone grafts & membranes	Lister	Actifuse Shape (size 1-2mm/contents 1.6 mL)Actifuse Shape (size 1-2mm/contents 15.8 mL)Actifuse Shape (size 1-2mm/contents 2.6 mL)Actifuse Shape (size 1-2mm/contents 8 mL)BioMend Absorbable Collagen MembraneBioMend Extend Absorbable Collagen MembraneBONE GRAFTING MATERIAL, SYNTHETIC ARA Kit Syringe delivery systemBONE GRAFTING MATERIAL, SYNTHETIC ARMBONE GRAFTING MATERIAL, SYNTHETIC Inducer bone graft delivery syringeDentoGen 23 more HeliMend Absorbable Collagen MembraneHeliMend Advanced Absorbable Collagen MembraneIP200 bone FillerIP200 Orthognathic SurgeryNanoGen GrafSetNovaBone Dental MorselsNovaBone Dental ParticulateNovaBone Dental PuttyNovaBone Dental Putty - Bioactive Synthetic Bone Graft (cartridge)NovaBone Dental Putty - Bioactive Synthetic Bone Graft (syringe)NovaBone Dental Putty - Bioactive Synthetic Bone Graft (tray)NovaBone Dental Putty - cartridgeNovaBone Dental Putty - syringeOraMem Absorbable Collagen MembraneOraMem Sustained Absorbable Collagen MembraneOsteograf N-300PerioGlasShefabone SCPCStraumann BoneCeramic506005078062 -Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 1.6 mL)506005078064-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 2.6 mL)506005078066-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 8 mL)506005078068-Bone Grafting Material, Synthetic Actifuse Shape (size 1-2mm/contents 15.8 mL)	2012
Bone PlateJEY · Class 2	Maxillofacial plates & screws	Lister	ACCESS PORT W / STABILITY 3/5 X 70MMBioplate Sterile KitsMacropore FX, PS, NS, LPMacropore MX Mandibular Fixation SystemMacropore Protective SheetMacropore PX Pediatric SystemTAUT04.503.122S04.50385S420.302S 67 more 420.303S420.304S420.401S420.402S420.403S420.40S420.44S420.45S421.302S421.303S421.304S421.531S421.532S421.533S421.534S421.535S421.536S421.537S421.538S421.539S421.540S421.541S421.542S421.543S421.544S421.545S421.546S421.547S42104S42105S42107S42108S42109S42111S42112S42113S42114S42115S42116S42117S42118S42119S42120S42140S42143S42144S42145S42148S42149S446.40S446.44S446.45S44614S44615S44617S44618S44619S44633S44634S44635S44636S44650S44651S44652S44653S44654S44655S	2013
Human Source Bone Grafting MaterialNUN · Class 2	Bone grafts & membranes	Maker	ACCELL CONNEXUSACCELL CONNEXUS KEYSTONE DENTALAlloSync CB Putty & Pastebone grafting material, human source ACCELL CONNEXUSbone grafting material, human source DYNABLAST PUTTY & PASTEbone grafting material, human source DYNAGRAFT D PUTTY & GELDYNABLAST PUTTY & PASTEDYNAGRAFT D PUTTY & GELORTHOBLAST II DBM PUTTY & PASTEORTHOBLAST II DBM PUTTY & PASTE, DYNABLAST PUTTY & PASTE 6 more PROGENIX® PLUSPROGENIX® PUTTYRegenafilRegenaformRegenaVateRegenerOss Putty Plus	2012
Dental NeedleDZM · Class 1	Dental needles & syringes	Lister	SimpleCAPX-TIP	2012
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Lister	CERTAIN® EP® TWIST LOCK TM COPINGCERTAIN® HEX TRY-IN SCREWCERTAIN® PICK-UP COPINGCERTAIN® STRAIGHT PICK UP COPINGCERTAIN® STRAIGHT PICK-UP COPINGCERTAIN® TWIST LOCK TM STRAIGHT TRANSFER COPINGConical Abutment Pick-Up CopingCONICAL EP® PICK-UP COPING (HEXED)CONICAL EP® PICK-UP COPING (NON-HEXED)CONICAL EP® TWIST LOCK TM COPING 29 more Disposable Countersink DrillDisposable Drill KitDisposable Pilot DrillDisposable Round DrillDisposable Twist DrillDisposable Twist Drill, Non-HubbedDrill Kit Parallel WalledDrill Kit TaperedDRILL STOP, 2.3MM-3.25MM X 10MMDRILL STOP, 2.3MM-3.25MM X 15MMDRILL STOP, 2.3MM-3.25MM X 20MMDRILL STOP, 4.25MM-5.25MM X 13MMDRILL STOP, 4.25MM-5.25MM X 18MMDRILL STOP, 4.25MM-5.25MM X 8.5MMIMPLANT EP® PICK-UP COPINGIMPLANT EP® TWIST LOCK TM COPINGIndex Coping - SurgicalMPLANT EP® PICK-UP COPINGPick-Up Impression CopingPROVIDE® IMPRESSION COPING 4.8MM(P) - 4MM POSTPROVIDE® IMPRESSION COPING 4.8MM(P) - 5.5MM POSTPROVIDE® IMPRESSION COPING 6.5MM(P) - 4MM POSTPROVIDE® IMPRESSION COPING 6.5MM(P) - 5.5MM POSTPROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 4MM POSTPROVIDE® IMPRESSION COPING WITH HOLES 4.8MM(P) - 5.5MM POSTPROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 4MM POSTPROVIDE® IMPRESSION COPING WITH HOLES 6.5MM(P) - 5.5MM POSTStandard Abutment Pick-Up CopingStandard Abutment Transfer Coping	2012
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Lister	ProGliderProTaper Gold	2017
Dental Diamond InstrumentDZP · Class 1	Dental burs & diamonds	Lister	BrasselerLGI¿SteriPrep¿	2012
Roll CottonEFN · Class 1	—	Lister	Dental Medical DevicesL FZUSS 0005 R07201 FBB {FIRST AID STER USP ROLL 1/2OZ}L FZUSS 0040 R02401 FBB {FIRST AID STER USP ROLL 4OZ/24}L FZUSS 0040 R02401 RT {RITE AID STER USP ROLL 4 OZ/24}L FZUSS 0160 R01201 US {USC STER USP ROLL 16 OZ/12}L GLDL 0001 R01201 US {USC 454G CANADA COT ROLL 12/1}Richmond Dental & Medical9901/509902/509903/25 9 more 9903/509905/509910/509911/509915/509916/509918/509920/509922/50	2013
Intraosseous Fixation ScrewDZL · Class 2	Maxillofacial plates & screws	Lister	JUGGERKNOT 1MM MINIJUGGERKNOT MINI SOFT ANCHOR311.5781S311.5791S	2013
Orthodontic Elastic BandECI · Class 1	Orthodontic wires & bands	Lister	Band, Elastic, Orthodontic14002/10014004/10014005/10014010/10014011/10014012/10014102/10014110/10014118/100 58 more 14162/10014202/10014203/5014204LT/10014205/5014220/10014364/10014601/2514602/10014602/5014602D/10014602G/2514605/10014606/10014608/10014612/10014702/10014702N/10014704/10014705/10014706/10014707/10014710/10014712/10014715/10014802/10014802/5014830/5014884/5014902/5014903/5014909/5014920/10014930/10018003/5018006/2018008/2518010/2019005/5019010/5019012/5019020/5019030/5019060/5019070/5019085/5019100/3019100/5019110/5019111/5019112/2419112/2519114/2419115/5019116/5019125/5019127/50987370/50	2012
Manual ToothbrushEFW · Class 1	Toothbrushes	Lister	Toothbrush Manual	2012
Dental BurEJL · Class 1	Dental burs & diamonds	Lister	BrasselerLGI¿SteriPrep¿	2012
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Lister	FlexAccess 04/15 21mmFlexAccess 04/15 25mmFlexAccess 04/15 30mmFlexAccess 04/20 21mmFlexAccess 04/20 25mmFlexAccess 04/20 30mmFlexAccess 04/25 21mmFlexAccess 04/25 25mmFlexAccess 04/25 30mmFlexAccess 04/30 21mm 39 more FlexAccess 04/30 25mmFlexAccess 04/30 30mmProGliderProTaper NextTrunatomyTRUShape 3D Conforming File Size 20 21mmTRUShape 3D Conforming File Size 20 25mmTRUShape 3D Conforming File Size 20 31mmTRUShape 3D Conforming File Size 25 21mmTRUShape 3D Conforming File Size 25 25mmTRUShape 3D Conforming File Size 25 31mmTRUShape 3D Conforming File Size 30 21mmTRUShape 3D Conforming File Size 30 25mmTRUShape 3D Conforming File Size 30 31mmTRUShape 3D Conforming File Size 40 21mmTRUShape 3D Conforming File Size 40 25mmTRUShape 3D Conforming File Size 40 31mmTruShape FilesTruShape Orifice Modifier 16mmWaveone gold filesWaveOne Gold GliderWaveOne Gold Reciprocating File Large 21mmWaveOne Gold Reciprocating File Large 25mmWaveOne Gold Reciprocating File Large 25mm DEMOWaveOne Gold Reciprocating File Large 31mmWaveOne Gold Reciprocating File Medium 21mmWaveOne Gold Reciprocating File Medium 25mmWaveOne Gold Reciprocating File Medium 25mm DEMOWaveOne Gold Reciprocating File Medium 31mmWaveOne Gold Reciprocating File Primary 21mmWaveOne Gold Reciprocating File Primary 21mm DEMOWaveOne Gold Reciprocating File Primary 25mmWaveOne Gold Reciprocating File Primary 25mm DEMOWaveOne Gold Reciprocating File Primary 31mmWaveOne Gold Reciprocating File Small 21mmWaveOne Gold Reciprocating File Small 21mm DEMOWaveOne Gold Reciprocating File Small 25mmWaveOne Gold Reciprocating File Small 25mm DEMOWaveOne Gold Reciprocating File Small 31mm	2019
External Mandibular Fixator and/or DistractorMQN · Class 2	Maxillofacial plates & screws	Lister	Macropore DX Distractor System03.305.500S	2013
General Purpose Dental TrayOFX · Class 1	—	Lister	General purpose dental tray	2017
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	HAND PIECEPeak PlasmaBlade TnA	2012
Extraoral with Timer X-Ray UnitEHD · Class 2	Dental X-ray units	Lister	—	2013
Endodontic Paper PointEKN · Class 1	Root canal filling materials	Lister	ABSORBENT S P P MAILLEFER W180 15ABSORBENT S P P MAILLEFER W180 15-40ABSORBENT S P P MAILLEFER W180 20ABSORBENT S P P MAILLEFER W180 25ABSORBENT S P P MAILLEFER W180 30ABSORBENT S P P MAILLEFER W180 35ABSORBENT S P P MAILLEFER W180 40ABSORBENT S P P MAILLEFER W180 45ABSORBENT S P P MAILLEFER W180 45-80ABSORBENT S P P MAILLEFER W180 50 59 more ABSORBENT S P P MAILLEFER W180 55ABSORBENT S P P MAILLEFER W180 60ABSORBENT S P P MAILLEFER W180 70ABSORBENT S P P MAILLEFER W180 80ABSORBENT S P P MAILLEFER W180 CABSORBENT S P P MAILLEFER W180 FABSORBENT S P P MAILLEFER W180 MABSORBENT S P P MAILLEFER W180 XCABSORBENT S P P MAILLEFER W180 XFABSORBENT S P P MAILLEFER W180 XXF-XCLEXICON ABS S P P ISO W180 15LEXICON ABS S P P ISO W180 15-40LEXICON ABS S P P ISO W180 20LEXICON ABS S P P ISO W180 25LEXICON ABS S P P ISO W180 30LEXICON ABS S P P ISO W180 35LEXICON ABS S P P ISO W180 40LEXICON ABS S P P ISO W180 45LEXICON ABS S P P ISO W180 45-80LEXICON ABS S P P ISO W180 50LEXICON ABS S P P ISO W180 55LEXICON ABS S P P ISO W180 60LEXICON ABS S P P ISO W180 70LEXICON ABS S P P ISO W180 80LEXICON ABS S P P W180 CLEXICON ABS S P P W180 FLEXICON ABS S P P W180 MLEXICON ABS S P P W180 X-CLEXICON ABS S P P W180 XFLEXICON ABS S P P W180 XXF-XCPrecise Dental560 ISO S P P C C E W144 100560 ISO S P P C C E W144 110560 ISO S P P C C E W144 120560 ISO S P P C C E W144 130560 ISO S P P C C E W144 140560 ISO S P P C C E W144 90560 ISO S P P C C E W144 90 - 140560 ISO S P P C C E W180 15560 ISO S P P C C E W180 15 - 40560 ISO S P P C C E W180 20560 ISO S P P C C E W180 25560 ISO S P P C C E W180 30560 ISO S P P C C E W180 35560 ISO S P P C C E W180 40560 ISO S P P C C E W180 45560 ISO S P P C C E W180 45 - 80560 ISO S P P C C E W180 50560 ISO S P P C C E W180 55560 ISO S P P C C E W180 60560 ISO S P P C C E W180 70560 ISO S P P C C E W180 80565 AUXILIARY S P P W144 X C565 AUXILIARY S P P W180 C565 AUXILIARY S P P W180 F565 AUXILIARY S P P W180 M565 AUXILIARY S P P W180 X F565 AUXILIARY S P P W180 XX F565 AUXILIARY S P P W180 XXF-C	2013
Root Canal PostELR · Class 1	Root canal filling materials	Lister	Surtex Sterile Posts	2021
Intraoral Synthetic BarrierNPK · Class 2	Bone grafts & membranes	Lister	barrier, synthetic, intraoral Straumann MembraGel	2012
Intraoral Animal Source BarrierNPL · Class 2	Bone grafts & membranes	Lister	OTA Collagen Biomaterials	2013
Animal Source Bone Grafting MaterialNPM · Class 2	Bone grafts & membranes	Lister	A-Graft BONE GRAFTING MATERIAL, ANIMAL SOURCE	2018
Dental Biologic MaterialNQA · Class 3	—	Lister	biologic material, dental Straumann Emdogain 0.3 ml, Multipack	2012
Dental Hygiene KitNXZ · Class 1	—	Lister	—	2025
Dental Prophylaxis KitNYC · Class 1	Dental hand instruments	Lister	—	2025
Endodontic KitNYD · Class 2	—	Lister	—	2025
Fixture Mount KitNYE · Class 1	Implant instruments & surgical kits	Lister	—	2025
Gingival Retraction KitNYF · Class 1	Dental hand instruments	Lister	—	2025
Lapping Tool KitNYG · Class 1	Dental hand instruments	Lister	—	2025
Plaque Disclosing KitNYH · Class 2	—	Lister	—	2025
Orthodontic Endosseous ImplantOAT · Class 2	—	Lister	SELF LIGATING SPIDER SCREW - STERILE	2016
Restorative Instrument and Component TrayOFW · Class 2	—	Lister	—	2025
Dental Implant Surgical TrayOFY · Class 1	Implant instruments & surgical kits	Lister	—	2025
Oral Irrigation KitOGT · Class 1	—	Lister	—	2025
Oral Surgery TrayPWL · Class 1	Dental hand instruments	Lister	—	2025
Orthodontic WireDZC · Class 1	Orthodontic wires & bands	Lister	IP200 Craniofacial Onlay	2016
Powered Bone DrillDZI · Class 2	Surgical drills & motors	Lister	0300.317S	2013
Manual Wire Driver and Bone DrillDZJ · Class 2	Surgical drills & motors	Lister	Propel Device, RT open / ClosedPropel Device, XL	2021
Mouth MirrorEAX · Class 1	Dental hand instruments	Lister	Mirror, Mouth	2017
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Lister	—	2017
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Lister	—	2018
Oral Cavity EvacuatorEHZ · Class 1	Suction & evacuation units	Lister	Safetrap Tissue Collector	2012
Operative Dental UnitEIA · Class 1	Dental chairs & operative units	Lister	—	2017
Irrigating Endodontic Periodontic SyringeEIC · Class 1	Dental hand instruments	Lister	—	2017
Rubber DamEIE · Class 1	Rubber dam systems	Lister	SILI01/12SILI02/12SILI023/8SILI026/20SILI03/36SILI11/12SILI12/12SILI13/12SILI14/12	2018
All Types RetractorEIG · Class 1	Dental hand instruments	Lister	—	2026
Dental Instrument HandleEJB · Class 1	Dental hand instruments	Lister	Handle, Instrument, Dental	2017
Cartridge SyringeEJI · Class 2	Dental needles & syringes	Lister	—	2012
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Lister	—	2012
Polishing Agent WheelEJQ · Class 1	Polishing & prophylaxis	Lister	—	2017
Operative Cutting InstrumentEKD · Class 1	Dental hand instruments	Lister	Propel Device PT contra angle	2012
Surgical Biopsy PunchEME · Class 1	Dental hand instruments	Lister	Disposa-DermSkin Biopsies/Skin Punch Disposa-Derm	2012
Massaging PickJET · Class 1	Floss & interdental cleaners	Lister	16101/10016102D/10016110/10016112/10016115/10016116/50	2018
Paper Saliva AbsorberKHR · Class 1	—	Lister	Ultracell	2013
Rotary Bone Cutting HandpieceKMW · Class 2	Surgical drills & motors	Lister	—	2018
Nose and Throat Ear CementNEA · Class 2	—	Lister	Otomimix	2016
Dental Bone Grafting Material with Biologic ComponentNPZ · Class 3	—	Lister	Pepgen P-15	2012
Dental Chair without Operative UnitNRU · Class 1	Dental chairs & operative units	Lister	—	2017
Patient Personal Hygiene KitNSB · Class 1	—	Lister	—	2026

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
Sterigenics Belgium (Fleurus) SRLFDA reg. 3004681519	Fleurus Hainaut, Belgium	Contract sterilizer
Sterigenics Belgium (Petit Rechain) SRLFDA reg. 3005941719	Verviers Liege, Belgium	Contract sterilizer
Sterigenics Denmark A/SFDA reg. 3006405073	Espergaerde Sjaelland, Denmark	Contract sterilizer
Sterigenics Italy SpAFDA reg. 3010407203	Minerbio Bologna, Italy	Contract sterilizer
Sterigenics Radiation Technologies, LLCFDA reg. 2024024	San Diego, CA, United States	Contract manufacturer, Contract sterilizer
Sterigenics S. de R.L. de C.V.FDA reg. 9616517	Tepeji del Rio de Ocampos Hidalgo, Mexico	Contract sterilizer
Sterigenics SASFDA reg. 3007156625	Rantigny Oise, France	Contract sterilizer
Sterigenics U.S. LLCFDA reg. 1054811	MULBERRY, FL, United States	Contract sterilizer
Sterigenics U.S. LLCFDA reg. 2953359	Hayward, CA, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 2029275	Corona, CA, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1036836	Haw River, NC, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 2219920	Rockaway, NJ, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 2245590	Salem, NJ, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1061124	Charlotte, NC, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 2022435	Tustin, CA, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1018470	Atlanta, GA, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1319639	Queensbury, NY, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1420032	Schaumburg, IL, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 1721676	Salt Lake City, UT, United States	Contract sterilizer
Sterigenics U.S., LLCFDA reg. 2029015	Ontario, CA, United States	Contract sterilizer
STERIGENICS UK LIMITEDFDA reg. 3015219237	Chesterfield Derbyshire, United Kingdom	Contract sterilizer
Sterigenics US LLCFDA reg. 1423662	Gurnee, IL, United States	Contract sterilizer
Sterigenics US LLCFDA reg. 1058584	Charlotte, NC, United States	Contract sterilizer
Sterigenics US LLCFDA reg. 3004111573	Grand Prairie, TX, United States	Contract sterilizer
Sterigenics US LLCFDA reg. 1649518	Fort Worth, TX, United States	Contract sterilizer
Sterigenics US LLCFDA reg. 2011171	Los Angeles, CA, United States	Contract sterilizer
Sterigenics US LLCFDA reg. 3002907620	West Memphis, AR, United States	Contract sterilizer
Sterigenics US, LLCFDA reg. 1526534	Lewis Center, OH, United States	Contract sterilizer
UNIDADE DE ESTERILIZACAO COTIA LTDA.FDA reg. 3005914490	Cotia Sao Paulo, Brazil	Contract manufacturer, Contract sterilizer

Other names on FDA records

Sterigenics US LLC · Sterigenics · Sterigenics Radiation Technologies, LLC · Sterigenics Denmark A/S · Sterigenics Belgium (Fleurus) SRL · Sterigenics S. de R.L. de C.V. · Sterigenics Belgium (Petit Rechain) SRL · Unidade de Esterilizacao Cotia Ltda. · Sterigenics Italy SpA · Sterigenics UK Limited

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029425). 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.