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
Insertion Instrument	INS-ANA-180	FDA UDI	Class I	Active
Closed Tray Transf.for Premium	A-TRAS-330	FDA UDI	Class II	Active
Non Retent. Long Hand Driver	BL-EX250	FDA UDI	Class I	Active
Transfer Echo For Global	U-CAMETRA2-380	FDA UDI	Class I	Active
Final Conical Drill Global	FU3-380-115	FDA UDI	Class I	Active
Post Screw For Prama Implant	L-VM-180	FDA UDI	Class I	Active
M-Two Instrument	M2200631	FDA UDI	Class I	Active
T-Connect For Single	L-BASTZR-S-500-4-05	FDA UDI	Class II	Active
Box For Pre-Made Abutment	PBOX-A-MDR-380-4-S	FDA UDI	Class I	Active
Drill	GS-F250-085-50	FDA UDI	Class I	Active
Analogue For Pre-Made	AS-ANA-MDR-425-1	FDA UDI	Class I	Active
Millable Titanium Abutment	U-CAMTABUF-380-12	FDA UDI	Class I	Active
Transgingival Healing Cap H2mm	A-TMGR-500-2	FDA UDI	Class II	Active
T-Connect For Implants	L-BASTZR-M-425-4-05	FDA UDI	Class II	Active
Teflon Cap Container For Ball	CONT-CAP-2	FDA UDI	Class I	Active
15gr Angle Pre-Made Post, Rep.	A-MA15-330	FDA UDI	Class II	Active
Snap On Cap For Closed Tray	AS-CAP-TRA-MDR-500-1	FDA UDI	Class I	Active
Holder For Premium	GS-MOU-A380	FDA UDI	Class I	Active
Right Angle Bone Tap	E-MS-500-CA	FDA UDI	Class I	Active
Supplementary Drills Set	L-INTEGRA-060	FDA UDI	Class I	Active
Straight Pre-Made Abutment	A-MD-TS-EX230-1	FDA UDI	Class II	Active
Straight Pad Abutment, H1.5 Mm	AS-PAD-AD425-15	FDA UDI	Class II	Active
Easy Mounter	GS-EASY-L-550-CA	FDA UDI	Class I	Active
Analogue For Plain Abutment	A-PLAIN-ANA	FDA UDI	Class II	Active
Drill	GS-F440-100-50	FDA UDI	Class I	Active
15gr Angle Pre-Made Post, Rep.	AS-MAR15-500	FDA UDI	Class II	Active
X-Ray Templates	E-L120	FDA UDI	Class I	Active
Premium Sp Implant Zirti	A-ZT-500SP-130	FDA UDI	Class II	Active
Shelta Implant Zirti Wide	SH-ZT-500SL-100	FDA UDI	Class II	Active
Straight Pre-Made Abutment	A-MD-TS-EX230-05	FDA UDI	Class II	Active
Open Tray Transfer For Abut.	A-TRABU-330	FDA UDI	Class II	Active
Mounter Stop Key	CM2	FDA UDI	Class I	Active
Rep. Straight Abutment, H2 Mm	A-ABU-330-2	FDA UDI	Class II	Active
Mounter Stop Key For	U-CM	FDA UDI	Class I	Active
Millable Titanium Abutment	SH-CAMTABUF-330-12	FDA UDI	Class I	Active
Locator Abutment Pre/Koh 3.30	1670	FDA UDI	Class II	Active
T-Connect For Single	A-TC-UNI-380-3	FDA UDI	Class II	Active
Straight Pre-Made Abutment	A-MD-TS-EX250-2	FDA UDI	Class II	Active
Transgingival Healing Cap H1, 3	A-TG-TMGR-M-13	FDA UDI	Class II	Active
Premium Implant Zirti Tg	A-ZT-500TG-060	FDA UDI	Class II	Active
Tapered Final Drill	GS-FK500-115-550	FDA UDI	Class I	Active
Instruments Tray For	REPLY-TRAY-INT	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP3-200-115	FDA UDI	Class I	Active
Castable Rep. Post With Gold	A-UCR-380-EX	FDA UDI	Class II	Active
T-Connect For Single Crown	A-TCR-S-380-4-2	FDA UDI	Class II	Active
Final Conical Drill Syra Short	SE-FK410-U	FDA UDI	Class I	Active
Castable Rep. Post With Crco	A-UCRCO-425-EX	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP3-280-085	FDA UDI	Class I	Active
Long Drill Diam. 4, 00 Mm	GS-F400-L	FDA UDI	Class I	Active
Millable Rep. Post For	AS-MFS-425	FDA UDI	Class II	Active

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