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
Hand Bone Tap For Global	U-MS-480	FDA UDI	Class I	Active
Non Rep. Tit.sleeve For Abut.	A-TG-CTABU-M-ROT	FDA UDI	Class II	Active
Pre-Made Rep. Post Straight	AS-MD-500-2	FDA UDI	Class II	Active
Pre-Made Rep. Abut Straight	AS-MD-425-2-S	FDA UDI	Class I	Active
T-Connect For Implants	L-BASTZR-M-425-6-05	FDA UDI	Class II	Active
Round Tip Osteotome For Global	OS-U-430-13-PT	FDA UDI	Class I	Active
Reply For Shelta Implant	SH-380-115-RP	FDA UDI	Class I	Active
Rep. Straight Abutment, H1 Mm	A-ABU-380-1	FDA UDI	Class II	Active
Box For Pre-Made Abutment	PBOX-AS-MDR-425-1	FDA UDI	Class I	Active
Pull-Up Transfer For Pre-Koh	A-TRARP-380	FDA UDI	Class II	Active
Surgical Kit	ZGSL-INT	FDA UDI	Class II	Active
Castable Post, Rep., Cr-Co	L-UCRCO-380-05	FDA UDI	Class I	Active
Post Screw For Prama Implant	L-VM-180-10	FDA UDI	Class I	Active
Simple Temp. Post Tit. Rep.	A-MPSA-330-EX	FDA UDI	Class II	Active
Easy Mounter	GS-EASY-AS-415-CA	FDA UDI	Class I	Active
Temp. Cap For Pre-Made Abut	A-CAP-CC-MDR-380-2-ROT	FDA UDI	Class I	Active
Xa Straight Int. Abu.	A-ABU-F-TS-330-4	FDA UDI	Class II	Active
Countersink Drill	A-FCC-425	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-AS-MDR-500-2	FDA UDI	Class I	Active
Implant Zirti	A-ZT-P500-070	FDA UDI	Class II	Active
M-Two Instrument	M225065N	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-A-MD-330-2-S	FDA UDI	Class I	Active
17gr Ang. Red. Pad Abut.	AS-PADR-AA500-175	FDA UDI	Class II	Active
Snap On Cap For Closed Tray	AS-CAP-TRA-MDR-500-1-S	FDA UDI	Class I	Active
Short Drill Diam. 3, 20 Mm	GS-F320-C	FDA UDI	Class I	Active
Removal Screw Kit	RSK-U	FDA UDI	Class II	Active
Transfer Echo For Outlink2	E-CAMETRA410	FDA UDI	Class I	Active
Flat Tip Osteotome For Shelta	SH-OS-500-100-PP	FDA UDI	Class I	Active
Plain Abutment H3 Mm	A-PLAIN-ABU380-3	FDA UDI	Class II	Active
Transgingival Healing Cap H5mm	AS-TMGA-425-5	FDA UDI	Class II	Active
Straight Red. Pad Abut.	A-PADR-AD380-40	FDA UDI	Class II	Active
Intermediate Drill	GS-F200-180-550	FDA UDI	Class I	Active
Pre-Made Rep. Post Anatomical	A-MDR-425-4	FDA UDI	Class II	Active
Implant Zirti	SH-ZT-PS380-150	FDA UDI	Class II	Active
30gr Angled Pad Abut., H5 Mm	A-PAD-AA330-305	FDA UDI	Class II	Active
Transgingival Healing Cap H3mm	A-TMG-425-3	FDA UDI	Class II	Active
Prama White Implant Zirti	LAW-ZT-425-150	FDA UDI	Class II	Active
Shelta Implant Zirti Regular	SH-ZT-425-115	FDA UDI	Class II	Active
Long Prosthetic Hand	HSML-20-EX	FDA UDI	Class I	Active
Temp. Cap For Pre-Made Abut	A-CAP-PRO-MDR-380-2-S	FDA UDI	Class I	Active
Retent.short R.a. Easy Insert	EASYC2-EX250-CA	FDA UDI	Class I	Active
T-Connect For Single	L-TCIN-425-05	FDA UDI	Class II	Active
Analogue For Pre-Made	AS-ANA-MDR-425-4	FDA UDI	Class I	Active
Millable Titanium Abutment	U-CAMTABUF-430-12	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-AS-MD-500-4-S	FDA UDI	Class I	Active
Snap On Cap For Closed Tray	PAD-CAP	FDA UDI	Class II	Active
T-Connect For Single	L-BASTZR-S-380-4-05	FDA UDI	Class II	Active
Surgical Cover Screw	L-VT-340	FDA UDI	Class II	Active
Pmma Cast.sleeve For Pad Abut.	PAD-CC	FDA UDI	Class II	Active
Prama White Implant Zirti	LALW-ZT-425-085	FDA UDI	Class II	Active

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