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
T-Connect For Single	AS-TC-UNI-425-3	FDA UDI	Class II	Active
Holder For Premium Sp	GS-MOU-A380SP	FDA UDI	Class I	Active
Transgingival Healing Cap H3mm	A-TMTCR-330-3	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP4-425-130	FDA UDI	Class I	Active
Simple Temp. Post Peek+tit Rep	AS-MPSCR-425	FDA UDI	Class II	Active
T-Connect For Implants Bridges	L-TCIN.-380-05-ROT	FDA UDI	Class II	Active
Prama White Implant Zirti	LAW-ZT-425-130	FDA UDI	Class II	Active
Countersink Drill	GS-FCS-A380	FDA UDI	Class I	Active
Long Stop H. 13, D. 4, 15 Mm	GS-STOP415-130	FDA UDI	Class I	Active
Locator Extra Light Retention	8548	FDA UDI	Class II	Active
Premium Straight Implant Zirti	A-ZT-425-180	FDA UDI	Class II	Active
Pre-Made Rep. Post Straight	AS-MD-500-4	FDA UDI	Class II	Active
Reply For Shelta Implant	SH-380-085-RP	FDA UDI	Class I	Active
Castable Rep. Post With Gold	AS-UCR-425-EX	FDA UDI	Class II	Active
Spare Cast. Sleeve For	A-CCBAS-330-6	FDA UDI	Class II	Active
Transgingival Healing Cap H3mm	A-TMGB-380-3	FDA UDI	Class II	Active
Reply For Global Implant	U-550-115-RP	FDA UDI	Class I	Active
Drill	GS-F320-200-50	FDA UDI	Class I	Active
Kohno Straight Implant Zt	K-ZT-380-115	FDA UDI	Class II	Active
Implant Zirti	A-ZT-P425-200	FDA UDI	Class II	Active
30gr Angled Pad Abut., H3 Mm	AS-PAD-AA425-303	FDA UDI	Class II	Active
Abutment Tit. D.12	AS-CAMT-425-12-SW	FDA UDI	Class I	Active
Prama Rf White Implant Zirti	LSW-ZT-500-130	FDA UDI	Class II	Active
Open Tray Transfer For Pre-Koh	A-TRA-500	FDA UDI	Class II	Active
Round Tip Osteotome For Shelta	SH-OS-500-150-PR	FDA UDI	Class I	Active
Straight Red. Pad Abut.	A-PADR-AD330-30	FDA UDI	Class II	Active
Surgical Cover Screw Shelta	SH-VT-380	FDA UDI	Class II	Active
Diamond Bur	FG862M/016C	FDA UDI	Class I	Active
Prama White Implant Zirti	LAW-ZT-380-115	FDA UDI	Class II	Active
Prama White Implant Zirti	LAW-ZT-500-100	FDA UDI	Class II	Active
Stop H.1 Mm For Drill	KM-S-01	FDA UDI	Class I	Active
Temp. Cap For Pre-Made Abut	AS-CAP-PRO-MD-425	FDA UDI	Class I	Active
Locator Abutment Pre/Koh Tg	2087	FDA UDI	Class II	Active
Prama Rf White Implant Zirti	LSLW-ZT-425-130	FDA UDI	Class II	Active
Rep. Straight Abutment, H2 Mm	A-ABU-500-2	FDA UDI	Class II	Active
Angled Pre-Made Abutment	A-MA07-TS-330-2	FDA UDI	Class II	Active
Flat Tip Osteotome For Shelta	SH-OS-425-150-PP	FDA UDI	Class I	Active
Torque Wrench With Lever	TWL	FDA UDI	Class I	Active
Countersink Drill	GS-FCS-SH425	FDA UDI	Class I	Active
Cast. Non Rep. Post With Gold	A-TG-UCABU-M-ROT	FDA UDI	Class II	Active
Premium Implant Zirti Tg	A-ZT-425TG-115	FDA UDI	Class II	Active
Stop For Short Drill	STOPS-425-060	FDA UDI	Class I	Active
Surgical Sleeve Diam.4, 15 Mm	GS-B415	FDA UDI	Class I	Active
Shelta Implant Zirti Regular	SH-ZT-600-100	FDA UDI	Class II	Active
Straight Pad Abutment, H1.5 Mm	AS-PAD-AD500-15	FDA UDI	Class II	Active
Straight Pre-Made Abutment	A-MD-TS-380-10	FDA UDI	Class II	Active
Tapered Final Drill	GS-FK500-130-550	FDA UDI	Class I	Active
Cylindrical Final Drill	GS-F300-050-415	FDA UDI	Class I	Active
30gr Angled Pad Abut., H3 Mm	A-PAD-AA425-303	FDA UDI	Class II	Active
Healing Abutment Prama White	LW-TMG-425-25-05	FDA UDI	Class II	Active

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