Manufacturer registered with FDA
SWEDEN & MARTINA S.p.A.
Due Carrare, Italy. Lists 6 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 975
- 510(k) clearances
- 62015–2019
- Markets registered in
- 56,078 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name SWEDEN & MARTINA S.p.A. as the manufacturer or the registration holder of a device.
RegisteredHome: ItalyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | SWEDEN & MARTINA S.p.A. | 6 clearances | 2015–2019 | Below |
| European Union | EUDAMED | Registration holder | SWEDEN & MARTINA S.P.A. | 6,056 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SWEDEN & MARTINA S.p.A.SWEDEN & MARTINA S.P.A. | 11 | 2013–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SWEDEN & MARTINA S.P.A | 7 | 2014–2020 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SWEDEN & MARTINA S.P.A | 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 SWEDEN & MARTINA S.p.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ABUTMENT PLAIN SCREW M2ABUTMENT PLAIN SCREWS M2ABUTMENT SCREWABUTMENT SCREW M1.8ABUTMENT SCREW M2ACTIVATOR SET FOR FEMALE PARTSADD-ON KITANALOGUE FOR ABUTMENTANALOGUE FOR BALL ATTACHMENTANALOGUE FOR IMPLANT 309 moreANALOGUE FOR IMPLANT D.3,80 MMANALOGUE FOR PAD ABUTMENTANALOGUE FOR PLAIN ABUTMENTANALOGUE FOR PRE-KOH TG ABUT.ANALOGUE FOR PRE-MADEANALOGUE FOR RED. PADANALOGUE FOR XA ABUTMENTANALOGUE,SOLID ONE-PIECE ABUT.ANGLE MEASUREMENT GUIDEANGLED PRE-MADE ABUTMENTBALL ATTACHMENT IMPL. PRE-KOHBALL ATTACHMENT IMPL. PRE/KOHBLACK O-RING BALL ATTACHMENTSBOX FOR PRE-MADE POSTSCARRIER FOR ANGLED ABUTMENTCAST. NON REP. POST WITH CR-COCAST. NON REP. POST WITH CRCOCAST. NON REP. POST WITH GOLDCAST. SLEEVE FOR 20GR ANGLEDCAST. SLEEVE FOR MULT. T-CONN.CAST. SLEEVE FOR SING. T-CONN.CAST.REP. POST WITH TITANIUMCASTABLE BAR ROUND PROFILECASTABLE BAR, OVOIDAL PROFILECASTABLE CAP FOR PREMADE POSTSCASTABLE CENTERING DEVICE FORCASTABLE REP. POST WITH CRCOCASTABLE REP. POST WITH GOLDCASTABLE SLEEVE FOR PLAINCLOSED TRAY TRANSF.FOR PRE-KOHCLOSED TRAY TRANSF.FOR PREMIUMCOMPLETE PACKAGING FORCONCAVE TIP OSTEOTOME D.1.60CONCAVE TIP OSTEOTOME D.2.40CONCAVE TIP OSTEOTOME D.20CONOMETRIC CAPCOUNTERSINK DRILL D.4.10 MMCYLINDRICAL PILOT DRILLDEPTH GAUGE HOLE IMPLANTSDESACTIVATOR MACRO FOR FEMALEEXTENSION FOR HAND SCREWDRIVEREXTENSION FOR SURGICAL DRILLSEXTRA LONG PROSTHETIC HANDEXTRA SHORT SURGICAL HANDFEMALE PART ASYMMETRICAL 3 L30FEMALE PART HOUSING T L47.5FEMALE PART T COMPLETE L47.5FINAL CILINDRICAL DRILLFINAL CONICAL DRILL SHELTAFINAL CYLINDRICAL DRILLFIXATION SCREW SGAUGE AIDGOLD CAP D 2.20 MMGOLD PINS U PROFILE FOR ROUNDGOLDEN BOX FOR O-RINGSHALF SHELL BALL SHAND BONE TAP FOR KOHNOHAND BONE TAP FOR PRE/KOHHAND BONE TAP FOR PREMIUMHAND BONE TAP FOR SHELTAHAND DRIVER FOR ABUTMENTHAND DRIVER FOR R.A. INSTRUM.HAND DRIVER FOR REP. ABUTMENTHAND DRIVER FOR TITANIUM CAPHAND KNOB FOR DRIVERS, BONEHAND PAD TRANSFER SCREWHAND RED. PAD TRANSFER SCREWHAND SCREWDRIVER FOR BALLHAND TRANSFER SCREWHEALING ABUTMENT PRAMA WHITEHEALING CAP FORHEALING CAP FOR ABUTMENTHEALING CAP FOR PLAIN ABUTMENTHEALING CAP FOR PRE-MADE POSTSHEALING PEEK CAP. NARROW PROF.HEALING PEEK CAP. WITH NARROWHEX KEY FOR FIXATION SCREWIMPLANT PLANNERIMPLANT ZIRTIIMPRESSION TAKING CAP FORINSERT POSITIONERINSTRUMENT SETINTERMEDIATE DRILLKOHNO ONE IMPLANT ZIRTIKOHNO STRAIGHT IMPLANT ZTLARGE BALL JOINT SLOCATOR ABUTMENT DRIVER (GOLDLOCATOR ABUTMENT PRE/KOH 3,30LOCATOR ABUTMENT PRE/KOH 3,80LOCATOR ABUTMENT PRE/KOH 4,25LOCATOR ABUTMENT PRE/KOH 50LOCATOR ABUTMENT PRE/KOH TGLOCATOR BLACK PROCESSINGLOCATOR EXTEND.RANGE RETENTIONLOCATOR EXTRA LIGHT RETENTIONLOCATOR FEMALE ANALOG (D.4 MM)LOCATOR IMPRESSION COPINGLOCATOR LIGHT RETENTION EXTENDLOCATOR LIGHT RETENTION MALE,LOCATOR MALE PROCESSING PACK.LOCATOR MALE REMOVAL (TIP END)LOCATOR PARALLEL POST (4 PCS)LOCATOR REPLACEMENT MALE,LOCATOR WHITE BLOCK-OUT SPACERLOCATORE CORE TOOL FOR LOCATORLONG PROSTHETIC HANDLONG SCREW DRIVER FOR LOCATORLONG SURGIC. HAND SCREWDRIVERMILLABLE POST, REP.MILLABLE POST, REP., EXTERNALMILLABLE POST, REP., INTERNALMILLABLE REP. POST FORMILLABLE TITANIUM ABUTMENTMILLABLE TITANIUM SLEEVEMOUNTER STOP KEYMOUNTER WITH SCREW FOR PRE/KOHNON REP. ABUTMENT FORNON REP. CAST.SLEEVE FOR ABUT.NON REP. TIT.SLEEVE FOR ABUT.NON RETENT. LONG HAND DRIVERNON RETENT. SHORT HAND DRIVERO-RING KIT FOR INSTRUMENTSOPEN TRAY TRANSF.FOR NON RIP.OPEN TRAY TRANSF.FOR PAD ABUT.OPEN TRAY TRANSF.FOR PRE-KOHTGOPEN TRAY TRANSF.FOR RED. PADOPEN TRAY TRANSF.FOR RIP.ABUT.OPEN TRAY TRANSFEROPEN TRAY TRANSFER FOR ABUT.OPEN TRAY TRANSFER FOR PRE-KOHOPEN TRAY TRANSFER FOR PREMIUMOPEN TRAY TRANSFER SCREW M1.8OPEN TRAY TRANSFER SCREW M2P_SLIM IMPLANT ZIRTIP.A.D. ABUTMENT SCREW M1.8P.A.D. ABUTMENT SCREW M2P.A.D. ABUTMENT SCREWS M1.8P.A.D. ABUTMENT SCREWS M2PARALLEL PINPEEK CAST.SLEEVE FOR PAD ABUT. | 2015 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ABUTMENT PLAIN SCREW M2ABUTMENT PLAIN SCREWS M2ABUTMENT SCREWABUTMENT SCREW M1.8ABUTMENT SCREW M2ACTIVATOR SET FOR FEMALE PARTSADD-ON KITANALOGUE FOR ABUTMENTANALOGUE FOR BALL ATTACHMENTANALOGUE FOR IMPLANT 306 moreANALOGUE FOR IMPLANT D.3,80 MMANALOGUE FOR PAD ABUTMENTANALOGUE FOR PLAIN ABUTMENTANALOGUE FOR PRE-KOH TG ABUT.ANALOGUE FOR PRE-MADEANALOGUE FOR RED. PADANALOGUE FOR XA ABUTMENTANALOGUE,SOLID ONE-PIECE ABUT.ANGLE MEASUREMENT GUIDEBALL ATTACHMENT IMPL. PRE-KOHBALL ATTACHMENT IMPL. PRE/KOHBLACK O-RING BALL ATTACHMENTSBOX FOR PRE-MADE POSTSCARRIER FOR ANGLED ABUTMENTCAST. NON REP. POST WITH CR-COCAST. NON REP. POST WITH CRCOCAST. NON REP. POST WITH GOLDCAST. SLEEVE FOR 20GR ANGLEDCAST. SLEEVE FOR MULT. T-CONN.CAST. SLEEVE FOR SING. T-CONN.CAST.REP. POST WITH TITANIUMCASTABLE BAR ROUND PROFILECASTABLE BAR, OVOIDAL PROFILECASTABLE CAP FOR PREMADE POSTSCASTABLE CENTERING DEVICE FORCASTABLE REP. POST WITH CRCOCASTABLE REP. POST WITH GOLDCASTABLE SLEEVE FOR PLAINCLOSED TRAY TRANSF.FOR PRE-KOHCLOSED TRAY TRANSF.FOR PREMIUMCOMPLETE PACKAGING FORCONCAVE TIP OSTEOTOME D.1.60CONCAVE TIP OSTEOTOME D.2.40CONCAVE TIP OSTEOTOME D.20COUNTERSINK DRILL D.4.10 MMCYLINDRICAL PILOT DRILLDEPTH GAUGE HOLE IMPLANTSDESACTIVATOR MACRO FOR FEMALEEXTENSION FOR HAND SCREWDRIVEREXTENSION FOR SURGICAL DRILLSEXTRA LONG PROSTHETIC HANDEXTRA SHORT SURGICAL HANDFEMALE PART ASYMMETRICAL 3 L30FEMALE PART HOUSING T L47.5FEMALE PART T COMPLETE L47.5FINAL CILINDRICAL DRILLFINAL CONICAL DRILL SHELTAFINAL CYLINDRICAL DRILLFIXATION SCREW SGAUGE AIDGOLD CAP D 2.20 MMGOLD PINS U PROFILE FOR ROUNDGOLDEN BOX FOR O-RINGSHALF SHELL BALL SHAND BONE TAP FOR KOHNOHAND BONE TAP FOR PRE/KOHHAND BONE TAP FOR PREMIUMHAND BONE TAP FOR SHELTAHAND DRIVER FOR ABUTMENTHAND DRIVER FOR R.A. INSTRUM.HAND DRIVER FOR REP. ABUTMENTHAND DRIVER FOR TITANIUM CAPHAND KNOB FOR DRIVERS, BONEHAND PAD TRANSFER SCREWHAND RED. PAD TRANSFER SCREWHAND SCREWDRIVER FOR BALLHAND TRANSFER SCREWHEALING ABUTMENT PRAMA WHITEHEALING CAP FORHEALING CAP FOR ABUTMENTHEALING CAP FOR PLAIN ABUTMENTHEALING CAP FOR PRE-MADE POSTSHEALING PEEK CAP. NARROW PROF.HEALING PEEK CAP. WITH NARROWHEX KEY FOR FIXATION SCREWIMPLANT PLANNERIMPLANT ZIRTIIMPRESSION TAKING CAP FORINSERT POSITIONERINSTRUMENT SETINTERMEDIATE DRILLKOHNO ONE IMPLANT ZIRTIKOHNO STRAIGHT IMPLANT ZTLARGE BALL JOINT SLOCATOR ABUTMENT DRIVER (GOLDLOCATOR ABUTMENT PRE/KOH 3,30LOCATOR ABUTMENT PRE/KOH 3,80LOCATOR ABUTMENT PRE/KOH 4,25LOCATOR ABUTMENT PRE/KOH 50LOCATOR ABUTMENT PRE/KOH TGLOCATOR BLACK PROCESSINGLOCATOR EXTEND.RANGE RETENTIONLOCATOR EXTRA LIGHT RETENTIONLOCATOR FEMALE ANALOG (D.4 MM)LOCATOR IMPRESSION COPINGLOCATOR LIGHT RETENTION EXTENDLOCATOR LIGHT RETENTION MALE,LOCATOR MALE PROCESSING PACK.LOCATOR MALE REMOVAL (TIP END)LOCATOR PARALLEL POST (4 PCS)LOCATOR REPLACEMENT MALE,LOCATOR WHITE BLOCK-OUT SPACERLOCATORE CORE TOOL FOR LOCATORLONG PROSTHETIC HANDLONG SCREW DRIVER FOR LOCATORLONG SURGIC. HAND SCREWDRIVERMILLABLE POST, REP.MILLABLE POST, REP., EXTERNALMILLABLE POST, REP., INTERNALMILLABLE REP. POST FORMOUNTER STOP KEYMOUNTER WITH SCREW FOR PRE/KOHNON REP. ABUTMENT FORNON REP. CAST.SLEEVE FOR ABUT.NON REP. TIT.SLEEVE FOR ABUT.NON RETENT. LONG HAND DRIVERNON RETENT. SHORT HAND DRIVERO-RING KIT FOR INSTRUMENTSOPEN TRAY TRANSF.FOR NON RIP.OPEN TRAY TRANSF.FOR PAD ABUT.OPEN TRAY TRANSF.FOR PRE-KOHTGOPEN TRAY TRANSF.FOR RED. PADOPEN TRAY TRANSF.FOR RIP.ABUT.OPEN TRAY TRANSFEROPEN TRAY TRANSFER FOR ABUT.OPEN TRAY TRANSFER FOR PRE-KOHOPEN TRAY TRANSFER FOR PREMIUMOPEN TRAY TRANSFER SCREW M1.8OPEN TRAY TRANSFER SCREW M2P_SLIM IMPLANT ZIRTIP.A.D. ABUTMENT SCREW M1.8P.A.D. ABUTMENT SCREW M2P.A.D. ABUTMENT SCREWS M1.8P.A.D. ABUTMENT SCREWS M2PARALLEL PINPEEK CAST.SLEEVE FOR PAD ABUT.PEEK SLEEVE FOR RED. PADPILOT DRILLPIN DIVISIBLE FOR OVOIDAL BARPLAIN ABUTMENT H2 MM | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DIAMOND BURPREPARATION DRILLS KIT FOR B.O.P.T.PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. | 2014 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | STARTER PACK | 2025 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | DENTAL HANDPIECE | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ABUTMENT ECHO GLOBALABUTMENT ECHO KOHNOABUTMENT ECHO OUTLINK2ABUTMENT ECHO PREMIUMABUTMENT ECHO PREMIUM-KOHNOABUTMENT SCREW M 2ABUTMENT SCREW M1.8ABUTMENT TIT. D.12ANALOGUE FOR ABUTMENTANALOGUE FOR PRAMA IMPLANT 325 moreANCHOR PINBONE EXPANDER FOR D.B.EBONE PROFILER SLEEVEBONE TAP FOR OUTLINK2BONE TAP PRE/OUT D. 3,30 MMBONE TAP PREMIUM D. 3,80 MMBONE TAP PREMIUM D. 4,25 MMBONE TAP PREMIUM D. 5,00 MMBONE TAP PREMIUM SP D.3,80 MMBOX FOR PRE-MADE ABUTMENTBREAK UP DRILL D. 30 MMBRUSHCARRIER FOR ANGLED ABUTMENTCASTABLE CAP FOR PREMADE ABUTCASTABLE POST, REP., CR-COCASTABLE POST,NON REP., CR-COCASTABLE POST,NON REP., GOLDCHAMFERED DRILL D. 30 MMCLOSED TRAY TRANSFERCLUTCH DRILLCONCAVE TIP OSTEOTOME D.1.60CONCAVE TIP OSTEOTOME D.2.40CONCAVE TIP OSTEOTOME D.20CONICAL DRILLCOUNTER ANGLE FOR SURGERY 20:1COUNTERSINK DRILLCOUNTERSINK DRILL D.4.10 MMCOUNTERSINK FOR OUTLINK2COUNTERSINK FOR PREMIUM SPCRCO POST ANATOMICALCRCO POST STRAIGHTCSR STOP FOR CYLINDRICAL DRILLCURVED HANDLECYLINDRICAL DRILLCYLINDRICAL FINAL DRILLCYLINDRICAL PILOT DRILLDEPTH GAUGEDEPTH GAUGE HOLE IMPLANTSDIGITAL ANALOGUEDOUBLE MOUNTER STOP KEY FORDOUBLE TIP PLUGGERDRILLEASY MOUNTEREXTENSION FOR HAND SCREWDRIVEREXTENSION FOR SURGICAL DRILLSEXTRA LONG PROSTHETIC HANDEXTRA SHORT SURGICAL HANDEXTRACTOR SCREWEXTRALONG PROSTHETIC HANDFINAL CONICAL DRILLFINAL CONICAL DRILL GLOBALFINAL CONICAL DRILL SHELTAFINAL CONICAL DRILL SYRA SHORTFINAL CYLINDRICAL DRILLFLAT TIP OSTEOTOME FOR SHELTAGLOBAL BONE EXPANDER KITGLOBAL BONE PROFILERGUIDED SURGERY PIVOTHAND BONE TAP FOR GLOBALHAND BONE TAP FOR KOHNOHAND BONE TAP FOR PRE/KOHHAND BONE TAP FOR PREMIUMHAND BONE TAP FOR SHELTAHAND DRIVER FOR ABUTMENTHAND DRIVER FOR R.A. INSTRUM.HAND DRIVER FOR TITANIUM CAPHAND KNOB FOR DRIVERS, BONEHAND SCREWDRIVER FOR BALLHANDLEHANDLE FOR D.B.E.SYSTEMHANDLE FOR MANUAL INSERTIONHEALING CAP FOR PRE-MADE ABUTHEXAGONAL SCREWDRIVER FORHOLDER FOR PREMIUMHOLDER FOR PREMIUM SPINITIAL DRILL BUILT-IN STOPINITIAL DRILL D. 20 MMINSERTION INSTRUMENTINSTRUMENT TRAY ECHOPLANINSTRUMENTS TRAY FORINTERMEDIATE DRILLINTERMEDIATE DRILL D. 2.50 MMINTERMEDIATE DRILL GLOBALINTRAORAL SCANBODYKIT D.B.E. SYSTEMLONG DIGITAL RETENTIVE DRIVERLONG DRILL DIAM. 2,00 MMLONG DRILL DIAM. 2,50 MMLONG DRILL DIAM. 2,80 MMLONG DRILL DIAM. 2,90 MMLONG DRILL DIAM. 3,00 MMLONG DRILL DIAM. 3,20 MMLONG DRILL DIAM. 3,30 MMLONG DRILL DIAM. 3,40 MMLONG DRILL DIAM. 3,60 MMLONG DRILL DIAM. 3,80 MMLONG DRILL DIAM. 4,00 MMLONG DRILL DIAM. 4,25 MMLONG DRIVER FOR GLOBAL IMPL.LONG PROSTHETIC HANDLONG SCREW DRIVER FOR LOCATORLONG STOP H. 13, D. 4,15 MMLONG STOP H. 13, D. 5,50 MMLONG STOP H. 15, D. 4,15 MMLONG STOP H. 15, D. 5,50 MMLONG SURGIC. HAND SCREWDRIVERM-TWO INSTRUMENTM.I.S.E. EVO KITMASTER SLEEVEMILLABLE CRCO ABUTMENTMILLABLE TITANIUM ABUTMENTMILLABLE TITANIUM SLEEVEMOUNTERMOUNTER HAND DRIVERMOUNTER OUTLINK2 D. 3,30 MMMOUNTER OUTLINK2 D. 4,10 MMMOUNTER OUTLINK2 D. 5,00 MMMOUNTER PRAMA, FOR SLEEVEMOUNTER SCREWMOUNTER STOP KEYMOUNTER STOP KEY FORMOUNTER TRAY ORGANIZERMOUNTER WITH SCREW FOR PRE/KOHMUCOTOMENECK POSITION PINNON RETENT. LONG HAND DRIVERNON RETENT. SHORT HAND DRIVERNON RETENTIVE DIGITAL DRIVERO-RING KIT FOR INSTRUMENTSOUTLINK2 SUPPLEMENTARY INSTR.OUTLINK2 SURGICAL KIT ECHOPLANPARALLEL PINPARALLELISM PIN WITH DEPTHPARALLELOMETERPEEK CAP FOR PREMADE POSTPEEK OSTEOTOME TIPPERI-SET , KIT FOR SURGICALPICK-UP TRANSFER FOR PRAMAPILOT DRILLPILOT DRILL GLOBAL | 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 SWEDEN & MARTINA S.p.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Jul 2019 | K180365 | PRAMA White Implant Systems | DZE Root-Form Endosseous Implant |
| 1 Feb 2018 | K161989 | PREMIUM Implant Systems SHELTA Implant Systems | NHA Endosseous Dental Implant Abutment |
| 21 Dec 2017 | K172560 | PREMIUM ONE Implant Systems | DZE Root-Form Endosseous Implant |
| 24 Mar 2017 | K162028 | PREMIUM - SHELTA Prosthetic Components | NHA Endosseous Dental Implant Abutment |
| 5 Dec 2016 | K162004 | PREMIUM Implant Systems SHELTA Implant Systems | NHA Endosseous Dental Implant Abutment |
| 2 Feb 2015 | K142242 | PREMIUM, SHELTA Implant Systems | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
SWEDEN & MARTINA S.p.A. 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: Aseptico, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Dec 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SWEDEN & MARTINA S.P.A.FDA reg. 3001082453 | Due Carrare Padova, Italy | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046682). 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.