Dental device manufacturers in Italy

67 companies have an FDA-registered establishment in Italy, across 68 sites. 59 manufacture dental devices there or own their specifications.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerAnkylos Cercon Balance · Ankylos Temporary Abutment Balance · Anti rotation cementing cap for connect abutment · Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants · +2531482026
Sybron Dental SpecialtiesUnited StatesMakerAlert · Alert Condensable Composite · Artiste Nano Composite · Build-It FR · +5532032026
Ivoclar Vivadent, AGUnited StatesMakerCAD/CAM CEREC Starter Kit · IPS Build-Up Liquid · IPS Classic · IPS Classic Powder Opaquer · +326942026
Cefla S.C.ItalyMakerEOS Compact · hyperion X5 · hyperion X9 pro · NewTom DCiS · +60152026
Mectron S.P.A.ItalyMakercombi touch · COMPACT PIEZO LED · Compact Piezo P2K - Powercare · K10 · +20112025
Jdentalcare SrlItalyMakerAbutment JDEvolution S · Abutment JDIcon · Abutment JDIcon Ultra S · Anatomic Abutment Angulated 15 H 1.5 JDEvolution Plus · +66052025
Zirkonzahn SrlItalyMakerAquarell · Color Liquids · ICE Prettau · ICE Transluzent Plus · +2102023
De Götzen S.R.L.ItalyMakerU-SENSE · U-SENSE HD · X-MIND optima · X-MIND optima 3D · +562023
Trident SRLItalyMakerBlu · Blu size 2 · BOOM sensor · BOOM sensor size 2 · +1452023
Leone S.P.A.ItalyMakerLEONE EXPANDERS · Mandibular advancers · Thermoplastic material · Orthodontic headgear, facemask/bow · +2942025
Overfibers S.R.L.ItalyMakerConical Drill # Large · Conical Drill # Medium · Conical Drill # Small · Cylindrical Drill # 0,8 · +7312025
Dental Manufacturing S.p.A.ItalyMakerACRY PRINT 3D RU-001 TEMPORARY · RUTHINIUM DISC · RUTHINIUM DISC MULTILAYER · RUTHINIUM DISC MULTILAYER SC · +1412026
Worldwork S.R.LItalyMakerMouthpiece, saliva ejector · CAPSULES, DENTAL AMALGAM · ALLOY, AMALGAM DENTAL AMALGAM12023
SWEDEN & MARTINA S.p.A.ItalyMakerABUTMENT PLAIN SCREW M2 · ABUTMENT PLAIN SCREWS M2 · ABUTMENT SCREW · ABUTMENT SCREW M1.8 · +59562019
Micerium S.P.A.ItalyMakerENA BOND · ENA ETCH · Ena Seal · TENDER ORTHO BOND · +3762011
Rhein'83 SrlItalyMakerKEF44SMD331 ALL ON FOUR EASY FIX SEVEN ø3,3 h.1 · KEF46NAC354 ALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4 · KEF46OCT33 ALL ON FOUR EASY FIX synOCTA O/I h.3,3 · KEF46PRK333 ALL ON FOUR EASY FIX PRE.KOHNO H. 3 · +62942018
Major Prodotti Dentari S.P.A.ItalyMakerLight-Cure.Tray · major.tray · MIT Light-Cure.Tray · major.base 20 · +2932008
Bioloren S.R.L.ItalyMakerFIBER DISK AND BLOCK PERMANENT, · TRILOR · Bioloren drill · Fiber Disks and Blocks · +332018
Hdc S.R.L.ItalyMakerSPIDER SCREW · STERILE SPIDER SCREW · Orthodontic Anchorage Attachment · Sterile Self Ligating Spider Screw32009
Lascod SpaItalyMakerAlginelle · Alginor · Ghenesyl Body Heavy Fast Set · Ghenesyl Body Heavy Normal Set · +4922020
Silfradent srlItalyMakerSurgybone · SUNSHINE S3S EVO BR · SUNSHINE S3S EVO SP · SUNSHINE S3S EVO SS · +212009
Epica InternationalUnited StatesMakerSEE FACTOR CT3 · SeeFactor CT312019
Nical SpaItalyMakerNICAL SMART MICRO, NSM1001AA,NPR1000AA, NPR1000VE.12015
MC Bio s.r.l.ItalyMakerMC Bio Supertack tack 3mm · MC Bio Supertack tack 4mm · MC Bio Supertack tack 5mm · Diamond Tissue Punch 10mm · +78——
Dentag SRLItalyMakerDENTAG · DenTag srl · DEN TAG S.R.L. · DenTag Srl——
Orthodontic Manufacturer SIA SRLItalyMakerLEONARDO PALATAL EXPANDER · SIA ORTHODONTIC MANUFACTURER · SMART CLICK · XP PALATAL EXPANDER · +21——
Mesa Italia S.r.l.ItalyMakerMAGNUM ADAMANTA 2 · MAGNUM ALBUM · MAGNUM CERALBUM · MAGNUM CERAMIC Co · +26——
Medesy SrlItalyMakermedesy · FAHNENSTOCK · syringe, cartridge——
XLINE S.r.l.ItalyMakerFONA XDC · IntraOs 70 · IntraOs DG · PantOs 16 xp · +15——
Nobil Metal S p AItalyMakerLV FIX · LV PAL · LV SAG · LV SFE · +15——
Euronda SPAItalyMakerMONOART EM15 SALIVA EJECTOR · MONOART COTTON ROLLS · Irrigation Set For Machinery · Manual Irrigation Set · +9——
Omnia SRLUnited StatesMakerIRRIGATION LINE · SplitAir · MAXIL · ASPIRATION SYSTEM · +9——
ASA DentalItalyMakerSALIVA EJECTOR DISPOSABLE · Dental Hand Instruments · Mouth Mirror · Rubber Dam Clamp · +8——
Luzzani Dental srlItalyMakerCGSMMGSG MINIMATE CG SYRINGE, ANGLED · CGSMMSSG MINIMATE CG SYRINGE, STRAIGHT · SB3SSG MINIBRIGHT SYRINGE 3F, STRAIGHT · SB6GSG MINIBRIGHT SYRINGE 3F, ANGLED · +8——
3DIEMME SrlItalyMakerEVOBITE · ANCHOR PINS · BONE CREST LEVELER · DRILL · +7——
FARO S.p.A.ItalyMakerE72 · EDI S UL · EDI TS UL · EVA · +4——
Pierrel S.p.A.ItalyMakerOrabloc thirtyES · Orabloc thirtyS · Orabloc twenty5L · Orabloc twenty7L · +3——
Industria Zingardi srlItalyMakerHydrosonic · Samba · Dental Floss——
Larident SRLItalyMakerCannula Zero Saliva Ejector · DEL JECT AMALGAM GUN · Cotton Roll Holder · IMPLA-CLEAN——
Spazzolificio Piave S.p.A.ItalyMakerCo Bigelow · Marvis · Piave · Silver Care——
Eptamed srlItalyMakerEquilibratori dentali · Freedom · Freedom Deep——
Tecnodent S.R.LItalyMakerLINDA EVO · LINDA NEXT · VALE——
ANCHIPLAST SrlItalyMakerSET FOR DENTAL IRRIGATION——
ELDO S.r.l.ItalyMakerACCESSORIES, RETRACTOR, DENTAL——
GEO s.r.l.ItalyMakerNuvola——
Intersurgical S.p.A.ItalyMakerCP903——
Medency SrlItalyMakerFibercure——
Nextmed srlsItalyMakerEnDrive——
PROFIMED GmbHItalyMakerClix Flosser Refill (only boobin)——
Sigmar Italia S.p.A.ItalyMakerDecapinol Oral Rinse——
TECNO-GAZ S.p.A.ItalyMakerSwan-I——
VANNINI DENTAL INDUSTRY S.r.l.ItalyMakerCromatic——
Artiglass S.r.l.ItalyMaker———
Creaproduct SrlItalyMaker———
Ghimas SPAItalyMaker———
North Bel Intl. S.r.l.United StatesMaker———
Pasini Laboratorio Chimico S.n.c.ItalyMaker———
Tecnofar S.p.AItalyMaker———
Uniontech, SRLItalyMaker———
Sotera Health LLCUnited StatesMakerAtlas Implant Packs · Celsite® Discreet STL201H · CERTAIN® FLAT IMPLANT COVER SCREW · CERTAIN® IMPLANT HEADLESS COVER SCREW · +951——
STERIS CorporationUnited StatesMakerAccumedix377 (LS) - Blue Sky Bio Dental Implant System - Internal Octagon Taper; Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System · Accumedix3772 (LS) - Blue Sky Bio Dental Implant System - Bio / Conus · +99——
Nuvola World S.R.L.ItalyForeign exporterFREEDOM · Freedom Deep · NUVOLA——
Agritalia S.r.l.ItalyForeign exporterDENTAL FLOSS——
IDS S.p.a.ItalyForeign exporterSwan-I——
Owenscorp Italia S.p.A.ItalyForeign exporterSELAHATIN AB——
GAMMATOM SrlItalyContract sterilizer———
STERIL VERONA s.r.l.ItalyContract sterilizer———

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026