Question 1

What types of medical devices does Sweden & Martina Inc manufacture?

Accepted Answer

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.

Question 2

Where is Sweden & Martina Inc based?

Accepted Answer

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.

Question 3

Which regulatory registries list devices manufactured by Sweden & Martina Inc?

Accepted Answer

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.

Question 4

How are devices from Sweden & Martina Inc classified under FDA regulations?

Accepted Answer

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.

Question 5

What is the purpose of the dental implant components and surgical tools produced by Sweden & Martina Inc?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Cyl. Intermediate Drill D.2.80	CSR-FI-280	FDA UDI	Class I	Active
Healing Cap For Pre-Made Abut	A-CAP-CG-MDR-330-1-S	FDA UDI	Class I	Active
Stop H.2 Mm For Drill	KM-S-02	FDA UDI	Class I	Active
Drill	GS-F440-085-50	FDA UDI	Class I	Active
Surgical Sleeve Diam.5, 50 Mm	GS-B550	FDA UDI	Class I	Active
Spare Cast. Sleeve For	A-CCABU-500-ROT	FDA UDI	Class II	Active
Parallelometer	PAR-INS-AS	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP4-200-070	FDA UDI	Class I	Active
M-Two Instrument	M210041	FDA UDI	Class I	Active
Straight Pad Abutment, H4 Mm	AS-PAD-AD425-40	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP4-250-130	FDA UDI	Class I	Active
M-Two Instrument	M235065	FDA UDI	Class I	Active
Closed Tray Transf.for Premium	A-TRAQ-425	FDA UDI	Class I	Active
Intermediate Drill	GS-F200-130-415	FDA UDI	Class I	Active
Pre-Made Rep. Abut Straight	A-MD-380-1-S	FDA UDI	Class I	Active
Pull-Up Transfer For Premium	A-TRARP-330	FDA UDI	Class II	Active
15gr Angle Pre-Made Post, Rep.	A-MAR15-425	FDA UDI	Class II	Active
Transgingival Healing Cap H3mm	AS-TMGR-425-3	FDA UDI	Class II	Active
Shelta Implant Zirti Regular	SH-ZT-600-130	FDA UDI	Class II	Active
Healing Abutment Prama White	LW-TMG-500-25-05	FDA UDI	Class II	Active
Rounded Drill D. 3.40 Mm	KM-F-R340	FDA UDI	Class I	Active
Stop For Conical Drill	SH-STOP4-FK600	FDA UDI	Class I	Active
Stop H.8 Mm For Drill	KM-S-08	FDA UDI	Class I	Active
Snap On Cap For Closed Tray	AS-CAP-TRA-MDR-425-1-S	FDA UDI	Class I	Active
Pre/Koh Bone Profiler	A-PAD-PS500-L	FDA UDI	Class I	Active
Transgingival Healing Cap H4, 3	A-TG-TMGR-W-43	FDA UDI	Class II	Active
Locator Abutment Driver (gold	8390	FDA UDI	Class II	Active
Prosthetic Box For Xa Post	PBOX-SHXA-330-2	FDA UDI	Class II	Active
Analogue For Abutment	SH-INT-CAMANA-500	FDA UDI	Class I	Active
Premium Straight Implant Zirti	A-ZT-500-085	FDA UDI	Class II	Active
15gr Angle Pre-Made Post, Rep.	A-TG-MAR15-M-60	FDA UDI	Class II	Active
Flat Tip Osteotome For Shelta	SH-OS-500-130-PP	FDA UDI	Class I	Active
Reply For Global Implant	U-430-130-RP	FDA UDI	Class I	Active
Crco Post Anatomical	L-CCRCOR-340-ROT	FDA UDI	Class I	Active
Double Tip Plugger D.3.40 And	KM-C-340-400	FDA UDI	Class I	Active
Millable Rep. Post For	A-MFS-425	FDA UDI	Class II	Active
M-Two Instrument	M230065	FDA UDI	Class I	Active
Millable Titanium Abutment	AS-CAMTABUF-425-08	FDA UDI	Class I	Active
Drill	GS-F200-100-50	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-A-MD-330-2	FDA UDI	Class I	Active
Universal Bone Profiler	GS-LC-550	FDA UDI	Class I	Active
Transgingival Healing Cap H3mm	A-TMGB-330-3	FDA UDI	Class II	Active
Spare Cast. Sleeve For	A-CCI-W	FDA UDI	Class II	Active
Open Tray Transfer For Pre-Koh	A-TRA-425	FDA UDI	Class II	Active
Kohno Straight Implant Zt	K-ZT-380-130	FDA UDI	Class II	Active
Temp. Cap For Pre-Made Abut	A-CAP-CC-MD-380-ROT	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP4-425-085	FDA UDI	Class I	Active
Cylindrical Final Drill	GS-F300-060-415	FDA UDI	Class I	Active
Round Tip Osteotome For Global	OS-U-550-85-PT	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-A-MDR-380-4	FDA UDI	Class I	Active

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