Registered with FDA
Sweden & Martina INC
Naperville, IL, United States. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 435
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Sweden & Martina INC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Lister | COLLAGEN DENTAL MEMBRANENEOMEM ECMNEOMEM FLEX PLUSOSSIX PLUSVolumax | 2016 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | CAST. NON REP. POST WITH CRCOCAST. NON REP. POST WITH GOLDCASTABLE REP. POST WITH CRCOCASTABLE REP. POST WITH GOLDHEALING ABUTMENT PRAMA WHITEMILLABLE POST, REP.MILLABLE REP. POST FORMILLABLE TITANIUM ABUTMENTMILLABLE TITANIUM SLEEVEOT EQUATOR 29 morePLAIN ABUTMENT H2 MMPLAIN ABUTMENT H3 MMPLAIN ABUTMENT H4 MMPRAMA RF WHITE IMPLANT ZIRTIPRAMA WHITE IMPLANT ZIRTIPRE-ANGLED REP. MILLABLE POSTPRE-MADE NON REP. POST FORPRE-MADE REP. POST ANATOMICALPRE-MADE REP. POST FOR PRAMAPRE-MADE REP. POST STRAIGHTPremium Implant Systems - Shelta Implant SystemsSET OT EQUATORSET OT EQUATOR S.BOXSIMPLE TEMP. POST PEEK+TIT REPSIMPLE TEMP. POST TIT. NON REPSIMPLE TEMP. POST TIT. REP.STRAIGHT PAD ABUTMENT, H1.5 MMSTRAIGHT PAD ABUTMENT, H3 MMSTRAIGHT PAD ABUTMENT, H4 MMTRANSGINGIVAL HEALING CAP H2MMTRANSGINGIVAL HEALING CAP H3MMTRANSGINGIVAL HEALING CAP H5MMTRANSGINGIVAL HEALING CAP H7MM15GR ANGLE PRE-MADE POST, REP.17GR ANGLED PAD ABUT., H3 MM17GR ANGLED PAD ABUT., H5 MM25GR ANGLE PRE-MADE POST, REP.30GR ANGLED PAD ABUT., H3 MM30GR ANGLED PAD ABUT., H5 MM | 2016 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | CAST. NON REP. POST WITH CRCOCAST. NON REP. POST WITH GOLDCASTABLE REP. POST WITH CRCOCASTABLE REP. POST WITH GOLDHEALING ABUTMENT PRAMA WHITEMILLABLE POST, REP.MILLABLE REP. POST FORPLAIN ABUTMENT H2 MMPLAIN ABUTMENT H3 MMPLAIN ABUTMENT H4 MM 25 morePRAMA RF WHITE IMPLANT ZIRTIPRAMA WHITE IMPLANT ZIRTIPRE-ANGLED REP. MILLABLE POSTPRE-MADE NON REP. POST FORPRE-MADE REP. POST ANATOMICALPRE-MADE REP. POST FOR PRAMAPRE-MADE REP. POST STRAIGHTPremium Implant Systems - Shelta Implant SystemsPREMIUM ONESIMPLE TEMP. POST PEEK+TIT REPSIMPLE TEMP. POST TIT. NON REPSIMPLE TEMP. POST TIT. REP.STRAIGHT PAD ABUTMENT, H1.5 MMSTRAIGHT PAD ABUTMENT, H3 MMSTRAIGHT PAD ABUTMENT, H4 MMTRANSGINGIVAL HEALING CAP H2MMTRANSGINGIVAL HEALING CAP H3MMTRANSGINGIVAL HEALING CAP H5MMTRANSGINGIVAL HEALING CAP H7MM15GR ANGLE PRE-MADE POST, REP.17GR ANGLED PAD ABUT., H3 MM17GR ANGLED PAD ABUT., H5 MM25GR ANGLE PRE-MADE POST, REP.30GR ANGLED PAD ABUT., H3 MM30GR ANGLED PAD ABUT., H5 MM | 2016 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Lister | Bone Grafting MaterialBONE GRAFTING MATERIAL IN DELIVERY APPLICATORTHE GRAFT | 2017 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | IMPLANT ANGLE HANDPIECEMICRONITI ROTARY ENDOHANDPIECE | 2025 |
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Lister | ECLIPSE | 2023 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | DIAMOND BURPREPARATION DRILLS KIT FOR B.O.P.T.PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. | 2018 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Lister | REMOVER, CROWN | 2022 |
| Preformed AnchorEJX · Class 1 | — | Lister | EASY FIX CASTABLE SLEEVEKIT EASY FIXKIT SEEGERLOCKING SCREWT-BASE EASY FIX | 2026 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | GUTTA-PERCHA POINTS | 2025 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | DENTAL HANDPIECE | 2025 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | CONTRAANGLE FOR SURGERY 1:1CONTRAANGLE FOR SURGERY 20:1 | 2021 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | 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 FIX INSERTER-TESTER-EXTRACTOREASY FIX T-BASE INSERTION TOOLEASY 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.SYSTEMHEALING 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 DEPTHPEEK CAP FOR PREMADE POSTPEEK OSTEOTOME TIPPERI-SET , KIT FOR SURGICALPICK-UP TRANSFER FOR PRAMAPILOT DRILLPILOT DRILL GLOBAL | 2018 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Lister | OPEN TEX | 2023 |
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Lister | BONE GRAFTING MATERIAL, HUMAN | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sweden & Martina INC 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: SWEDEN & MARTINA S.p.A. (4), Collagen Matrix, Inc. (4), Datum Dental, Ltd. (3), PURGO BIOLOGICS Inc. (2), Aseptico, Inc. (2), Biomatlante (2), Saeshin Precision Co., Ltd. (1), CreoDent Prosthetics LTD (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 May 2023 | K222549 | OpenTex | PURGO BIOLOGICS Inc. | NPK Intraoral Synthetic Barrier |
| 26 Nov 2019 | K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 8 Jul 2019 | K180365 | PRAMA White Implant Systems | SWEDEN & MARTINA S.p.A. | DZE Root-Form Endosseous Implant |
| 20 Jul 2018 | K173188 | The Graft Natural Bone Substitute | PURGO BIOLOGICS Inc. | NPM Animal Source Bone Grafting Material |
| 1 Feb 2018 | K161989 | PREMIUM Implant Systems SHELTA Implant Systems | SWEDEN & MARTINA S.p.A. | NHA Endosseous Dental Implant Abutment |
| 21 Dec 2017 | K172560 | PREMIUM ONE Implant Systems | SWEDEN & MARTINA S.p.A. | DZE Root-Form Endosseous Implant |
| 18 Jul 2017 | K163714 | OSSIX BONE | Datum Dental, Ltd. | NPM Animal Source Bone Grafting Material |
| 18 Jul 2017 | K170100 | CreoDent Solidex Customized Abutment and Screw | CreoDent Prosthetics LTD | NHA Endosseous Dental Implant Abutment |
| 9 Feb 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 4 Aug 2016 | K160281 | OSSIX PLUS | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 4 Aug 2016 | K153549 | OSSIX VOLUMAX | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 25 Nov 2015 | K142211 | OT EQUATOR | Rhein'83 Srl | NHA Endosseous Dental Implant Abutment |
| 2 Feb 2015 | K142242 | PREMIUM, SHELTA Implant Systems | SWEDEN & MARTINA S.p.A. | DZE Root-Form Endosseous Implant |
| 31 Dec 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 5 Nov 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 16 Jul 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | Collagen Matrix, Inc. | NPM Animal Source Bone Grafting Material |
| 10 Jan 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | Hans Biomed Corp. | NUN Human Source Bone Grafting Material |
| 11 Jul 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE | Kensey Nash Corporation | NPL Intraoral Animal Source Barrier |
| 11 Aug 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | Collagen Matrix, Inc. | NPL Intraoral Animal Source Barrier |
| 15 Mar 2010 | K093122 | MBCP+ | Biomatlante | LYC Synthetic Bone Grafting Material |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW Rotary Bone Cutting Handpiece |
| 2 Jun 2006 | K060732 | MBCP GEL | Biomatlante | LYC Synthetic Bone Grafting Material |
| 22 Feb 2006 | K053260 | OSSIX -PLUS | Colbar Lifescience , Ltd. | NPL Intraoral Animal Source Barrier |
| 3 May 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SWEDEN & MARTINA INCFDA reg. 3011276344 | Naperville, IL, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048147). 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.