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Sign in to claim this brandSWEDEN & MARTINA INC
US
Last updated September 17, 2026
What SWEDEN & MARTINA INC makes
The company produces dental implant components and surgical tools, including two-piece screw endosteal implants, preformed permanent and temporary suprastructures, reusable dental drill bits, and rotary endodontic files. Their portfolio also covers reusable surgical kits for dental and maxillofacial procedures, diamond dental burs, and specialized fixtures like transfer echoes, abutments, and healing caps.
These devices are classified as Class I and Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sweden & Martina Inc manufacture?
Sweden & Martina Inc specializes in dental implant components and surgical tools. Their portfolio includes two-piece screw endosteal dental implants, preformed permanent and temporary suprastructures for implants, reusable dental drill bits, rotary endodontic files, and reusable surgical kits for dental and maxillofacial procedures. They also produce specialized fixtures like transfer echoes, abutments, and transgingival healing caps, all designed for dental restoration and implantology.
Where is Sweden & Martina Inc based?
Sweden & Martina Inc is headquartered in the United States. The company’s primary operations and manufacturing are conducted within the country, though specific locations or facilities are not detailed in the available information.
Which regulatory registries list devices manufactured by Sweden & Martina Inc?
Devices produced by Sweden & Martina Inc are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for regulated medical devices in the United States, including those classified under FDA guidelines.
How are devices from Sweden & Martina Inc classified under FDA regulations?
The devices manufactured by Sweden & Martina Inc fall under two classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.
What is the purpose of the dental implant components and surgical tools produced by Sweden & Martina Inc?
The dental implant components and surgical tools produced by Sweden & Martina Inc are designed to support dental restoration procedures, particularly for patients requiring implants. These include tools for preparing the jawbone (e.g., drill bits and taps), components for securing implants (e.g., abutments and screws), and structures for restoring missing teeth (e.g., permanent and temporary suprastructures). The reusable and single-use items ensure precision, durability, and compliance with dental implantology standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 916 SPINDLETREE AVENUE, Naperville, IL, 60565
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3011276344
- DUNS Number
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Catalogue (2631)
Page 23 of 53| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Countersink Drill | GS-FCS-A500 | FDA UDI | Class I | Active |
| Temp. Cap For Pre-Made Abut | A-CAP-PRO-MD-330 | FDA UDI | Class I | Active |
| Millable Crco Abutment | U-CAMCABUF-480-12 | FDA UDI | Class I | Active |
| Abutment Screw M1.8 | L-VMS-180 | FDA UDI | Class II | Active |
| Healing Cap For Pre-Made Posts | A-TG-CAPGM-W-70 | FDA UDI | Class II | Active |
| Post Screw M1.8 | VM2-180 | FDA UDI | Class II | Active |
| Flat Tip Osteotome For Shelta | SH-OS-425-100-PP | FDA UDI | Class I | Active |
| Stop For Conical Drill | U-STOP3-380 | FDA UDI | Class I | Active |
| Bone Profiler Sleeve | A-PAD-GUI-PS-250 | FDA UDI | Class I | Active |
| Neck Position Pin | L-PP-115 | FDA UDI | Class I | Active |
| Concave Tip Osteotome D.2.00 | E-OS-200-PC | FDA UDI | Class I | Active |
| Final Conical Drill Shelta | SH-FK500-100 | FDA UDI | Class I | Active |
| Prama Rf White Implant Zirti | LSW-ZT-500SL-085 | FDA UDI | Class II | Active |
| Round Tip Osteotome D.0.90 | E-OS-090-PP | FDA UDI | Class I | Active |
| Shelta Implant Zirti Regular | SH-ZT-380-150 | FDA UDI | Class II | Active |
| 30gr Angled Pad Abut., H5 Mm | AS-PAD-AA425-305 | FDA UDI | Class II | Active |
| Temp. Cap For Pre-Made Abut | AS-CAP-CC-MDR-500-2-ROT | FDA UDI | Class I | Active |
| Pick-Up Transfer For Prama | L-TRA-425 | FDA UDI | Class I | Active |
| Mounter Prama, For Sleeve | GS-MOU-L550 | FDA UDI | Class I | Active |
| Prama Rf White Implant Zirti | LSW-ZT-380SL-100 | FDA UDI | Class II | Active |
| Shelta Implant Zirti Regular | SH-ZT-425-085 | FDA UDI | Class II | Active |
| Premium Implant Zirti Tg | A-ZT-380TG-070 | FDA UDI | Class II | Active |
| Simple Temp.post Peek External | A-TG-MPSP-M | FDA UDI | Class II | Active |
| Transgingival Healing Cap H1.3 | A-TG-TMG-M-13 | FDA UDI | Class II | Active |
| Titanium Cap For Standard Ball | CAP-TIT-1 | FDA UDI | Class II | Active |
| T-Connect For Implants | A-BASTZR-M-380-6 | FDA UDI | Class II | Active |
| Drill | GS-F-LON-200-50 | FDA UDI | Class I | Active |
| Prama Rf White Implant Zirti | LSW-ZT-425-060 | FDA UDI | Class II | Active |
| Titanium Sleeve For Non Rep. | A-PLAIN-CT500 | FDA UDI | Class II | Active |
| Reply For Shelta Implant | SH-500-115-RP | FDA UDI | Class I | Active |
| Open Tray Transfer | A-PLAIN-TRA-500 | FDA UDI | Class II | Active |
| Premium One Implant Zirti | AS-ZT-425-070 | FDA UDI | Class II | Active |
| Prama White Implant Zirti | LASW-ZT-380-085 | FDA UDI | Class II | Active |
| Temp. Cap For Pre-Made Abut | AS-CAP-CC-MDR-500-1 | FDA UDI | Class I | Active |
| Temp. Cap For Pre-Made Abut | AS-CAP-CC-MDR-500-1-S-ROT | FDA UDI | Class I | Active |
| Plain Abutment H3 Mm | AS-PLAIN-ABU500-3 | FDA UDI | Class II | Active |
| Straight Pre-Made Abutment | A-MD-TS-330-20 | FDA UDI | Class II | Active |
| Implant Zirti | A-ZT-P380-180 | FDA UDI | Class II | Active |
| Intermediate Drill | GS-FK250-100-415 | FDA UDI | Class I | Active |
| Castable Rep. Post With Crco | AS-UCRCO-500-EX | FDA UDI | Class II | Active |
| Locator Abutment Pre/Koh Tg | 2082 | FDA UDI | Class II | Active |
| Pre-Made Non Rep. Post For | L-MDT.-340-10-ROT | FDA UDI | Class II | Active |
| Drill | GS-F200-070-50 | FDA UDI | Class I | Active |
| Analogue, Solid One-Piece Abut. | A-TG-ANAM-M-70 | FDA UDI | Class II | Active |
| Mounter | GS-MOU-AS380-50-6 | FDA UDI | Class I | Active |
| Pre-Made Rep. Abut Anatomical | AS-MDR-500-1-S | FDA UDI | Class I | Active |
| Peek Cap For Premade Post | SH-CP-MD-F-380 | FDA UDI | Class I | Active |
| Cylindrical Final Drill | GS-F300-085-415 | FDA UDI | Class I | Active |
| Right Angle Screwdriver | HSMXS-20-CA | FDA UDI | Class I | Active |
| Millable Crco Abutment | A-CAMCABUF-425-08 | FDA UDI | Class I | Active |
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