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
Pre-Made Non Rep. Post For	L-MD-340-6-ROT	FDA UDI	Class II	Active
Surgical Kit For Syra Short	ZSYRASHORT-INT	FDA UDI	Class I	Active
Prama Rf White Implant Zirti	LSSW-ZT-380-100	FDA UDI	Class II	Active
Prama White Implant Zirti	LALW-ZT-500-100	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP3-280-130	FDA UDI	Class I	Active
Intermediate Drill	FGS-425/540	FDA UDI	Class I	Active
Ball Attachment Impl. Pre/Koh	A-AS-330-4	FDA UDI	Class II	Active
Intermediate Drill	GS-F250-070-415	FDA UDI	Class I	Active
Conical Drill	FK250-L-SW	FDA UDI	Class I	Active
Abutment Screw	A-VMA-180	FDA UDI	Class II	Active
Conometric Cap	CAP2-TS-PIN	FDA UDI	Class II	Active
Pull-Up Transfer	AS-TRARP-500	FDA UDI	Class I	Active
Reply For Shelta Implant	SH-500-100-RP	FDA UDI	Class I	Active
Round Tip Osteotome For Shelta	SH-OS-380-150-PR	FDA UDI	Class I	Active
Outlink2 Bone Profiler	E-PAD-PS410-S	FDA UDI	Class I	Active
T-Connect For Single Crown	A-TCR-S-330-4-2	FDA UDI	Class II	Active
Cast.rep. Post With Titanium	A-UCTR-380-EX	FDA UDI	Class II	Active
Stop For Short Drill	STOPS4-200-060	FDA UDI	Class I	Active
Cast. Non Rep. Post With Gold	AS-UCR-425	FDA UDI	Class II	Active
T-Connect For Single	PADR-TC-S-4	FDA UDI	Class II	Active
Box For Pre-Made Abutment	PBOX-AS-MD-425-1	FDA UDI	Class I	Active
Millable Titanium Abutment	A-CAMTABUF-330-08	FDA UDI	Class I	Active
P_slim Implant Zirti	LASW-ZT-330-130	FDA UDI	Class II	Active
Transfer For Pre-Made	SH-TRA-MD-F-330	FDA UDI	Class II	Active
Castable Rep. Post With Gold	A-UCR-330-EX	FDA UDI	Class II	Active
Black O-Ring Ball Attachments	1500503	FDA UDI	Class II	Active
Impression Taking Cap For	CAP-MEFL-5	FDA UDI	Class II	Active
Mounter Hand Driver	GS-MOU-DG	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP3-340-150	FDA UDI	Class I	Active
Prama Rf White Implant Zirti	LSLW-ZT-425-115	FDA UDI	Class II	Active
Bone Tap For Outlink2	GS-MS-E410	FDA UDI	Class I	Active
Reply For Shelta Implant	SH-425-085-RP	FDA UDI	Class I	Active
M-Two Instrument	M250045	FDA UDI	Class I	Active
M-Two Instrument	M225061	FDA UDI	Class I	Active
Locator Male Removal (tip End)	8397	FDA UDI	Class II	Active
Plain Abutment H4 Mm	A-PLAIN-ABU-380C-4	FDA UDI	Class II	Active
B-4u Instrument	B2231	FDA UDI	Class I	Active
Healing Abutment Prama White	LW-TMG-380-25-05	FDA UDI	Class II	Active
T-Connect For Implants Bridges	L-TCIN.-500-05-ROT	FDA UDI	Class II	Active
Spare Cast. Sleeve For	A-CCBAS-500-6	FDA UDI	Class II	Active
Castable Post, Non Rep., Gold	L-UCR-380-05-ROT	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP4-250-150	FDA UDI	Class I	Active
Implant Zirti	A-ZT-P425-150	FDA UDI	Class II	Active
Pre-Made Rep. Abut Straight	A-MD-330-4-S	FDA UDI	Class I	Active
Short Stop H. 10, D. 5, 50 Mm	GS-STOP550-100	FDA UDI	Class I	Active
Non Retent. Short Hand Driver	BC-EX230	FDA UDI	Class I	Active
Tapered Final Drill	GS-FK380-130-415	FDA UDI	Class I	Active
Extralong Prosthetic Hand	L-HSMXL-EX	FDA UDI	Class I	Active
Cylindrical Pilot Drill	FPT5-200-LXS	FDA UDI	Class I	Active
Round Tip Osteotome For Global	OS-U-430-85-PT	FDA UDI	Class I	Active

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