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
Pull-Up Transfer For Pre-Koh	A-TRARP-425	FDA UDI	Class II	Active
X-Ray Templates For Syra And	SE-L120	FDA UDI	Class I	Active
M-Two Instrument	M2RF15	FDA UDI	Class I	Active
Short Drill Diam. 2, 80 Mm	GS-F280-C	FDA UDI	Class I	Active
Transfer Echo For Premium	A-CAMETRA330	FDA UDI	Class I	Active
Hand Driver For Rep. Abutment	A-TG-AVVABUR	FDA UDI	Class II	Active
Stop For Conical Drill	STOP-3842-260-SW	FDA UDI	Class I	Active
Analogue For Plain Abutment	A-PLAIN-ANA-330	FDA UDI	Class II	Active
Prama Rf White Implant Zirti	LSW-ZT-380SL-180	FDA UDI	Class II	Active
Prosthetic Screw M1.4 For	PAD-VP-140	FDA UDI	Class II	Active
Surgical Kit	ZGSE-2DRILL-INT	FDA UDI	Class II	Active
Millable Crco Abutment	A-TG-CAMCABUF-M08	FDA UDI	Class I	Active
Digital Analogue	A-ANA-330-DIG	FDA UDI	Class I	Active
17gr Ang. Est. Pad Abut.	AS-PADE-AA500-173	FDA UDI	Class II	Active
Stop For Conical Drill	STOP-2025-220-SW	FDA UDI	Class I	Active
Stop For Conical Syra Short	SE-STOP-FK500-050	FDA UDI	Class I	Active
Millable Crco Abutment	SH-CAMCABUF-330-12	FDA UDI	Class I	Active
25gr Angle Pre-Made Post, Rep.	A-MAR25-380	FDA UDI	Class II	Active
Premium Straight Implant Zirti	A-ZT-500-070	FDA UDI	Class II	Active
Spiral Drill	FC-EXTRACTOR	FDA UDI	Class I	Active
Analogue For Abutment	A-ANABU-330	FDA UDI	Class II	Active
Temp. Cap For Pre-Made Abut	AS-CAP-PRO-MDR-425-2-S	FDA UDI	Class I	Active
Analogue For Pre-Made	A-ANA-MDR-380-4-S	FDA UDI	Class I	Active
Digital Analogue	SH-ANA-500-DIG	FDA UDI	Class I	Active
Round Tip Osteotome For Global	OS-U-380-13-PT	FDA UDI	Class I	Active
Snap On Cap For Closed Tray	AS-CAP-TRA-MDR-425-1	FDA UDI	Class I	Active
Transgingival Healing Cap H2, 8	A-TG-TMGR-M-28	FDA UDI	Class II	Active
Round Tip Osteotome For Shelta	SH-OS-425-100-PR	FDA UDI	Class I	Active
Drill	GS-F290-150-50	FDA UDI	Class I	Active
Universal Bone Profiler	GS-LC-415	FDA UDI	Class I	Active
Short Drill Diam. 2, 90 Mm	GS-F290-C	FDA UDI	Class I	Active
Castable Sleeve For Plain	A-PLAIN-CC330	FDA UDI	Class II	Active
Kohno One Implant Zirti	KS-ZT-425-130	FDA UDI	Class II	Active
Prama Rf White Implant Zirti	LSLW-ZT-500SL-100	FDA UDI	Class II	Active
Straight Pad Abutment, H4 Mm	AS-PAD-AD500-40	FDA UDI	Class II	Active
Abutment Screw M 2	GS-VTMOU-200-S	FDA UDI	Class I	Active
Surgical Kit	ZPREKOH-INT	FDA UDI	Class II	Active
Surgical Cover Screw	A-TG-VT-M	FDA UDI	Class II	Active
Prama Rf White Implant Zirti	LSW-ZT-380-115	FDA UDI	Class II	Active
Short Drill Diam. 4, 00 Mm	GS-F400-C	FDA UDI	Class I	Active
Plain Abutment H4 Mm	AS-PLAIN-ABU500-4	FDA UDI	Class II	Active
P_slim Implant Zirti	LASW-ZT-330-100	FDA UDI	Class II	Active
Box For Pre-Made Abutment	PBOX-AS-MDR-425-2-S	FDA UDI	Class I	Active
Healing Abutment Prama White	LW-TMG-500-35-05	FDA UDI	Class II	Active
Analogue, Solid One-Piece Abut.	A-TG-ANAM-W-70	FDA UDI	Class II	Active
Implant Zirti	A-ZT-P380-220	FDA UDI	Class II	Active
Abutment Tit. D.12	A-CAMT-500-12-SW	FDA UDI	Class I	Active
Long Prosthetic Hand	L-HSML-EX	FDA UDI	Class I	Active
Drill	GS-F290-200-50	FDA UDI	Class I	Active
Xa Straight Int. Abu.	A-ABU-F-TS-330-6	FDA UDI	Class II	Active

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