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
Stop For Cylindrical Drill	STOP4-200-150	FDA UDI	Class I	Active
Abutment Tit. D.12	A-CAMT-380-12-SW	FDA UDI	Class I	Active
Retent.easy Insert Hand Driver	EASY4-EX230-EX	FDA UDI	Class I	Active
Drill	GS-F320-085-50	FDA UDI	Class I	Active
Pre-Made Rep. Abut Anatomical	A-MDR-330-2-S	FDA UDI	Class I	Active
Implant Zirti	SH-ZT-PS425SL-085	FDA UDI	Class II	Active
T-Connect For Single	A-BASTZR-S-380	FDA UDI	Class II	Active
Castable Cap For Premade Posts	A-TG-CAPCM-W-ROT	FDA UDI	Class II	Active
Pre-Made Straight Abut. For	A-PLAIN-MDT-10	FDA UDI	Class II	Active
Millable Post, Rep.	A-MFR-380	FDA UDI	Class II	Active
Surgical Kit For Csr-Dat	ZCSR-INT	FDA UDI	Class I	Active
Analogue For Pre-Made	ANA-TS	FDA UDI	Class II	Active
Conometric Cap	CAP2-TS-PRO	FDA UDI	Class II	Active
Plain Abutment H4 Mm	A-PLAIN-ABU380-4	FDA UDI	Class II	Active
Cylindrical Final Drill	GS-F300-070-415	FDA UDI	Class I	Active
Initial Drill D. 2.00 Mm	KM-F-200	FDA UDI	Class I	Active
Castable Bar, Ovoidal Profile	BARC-CAV-TIT	FDA UDI	Class II	Active
Cast. Sleeve For 20gr Angled	A-TG-CC-MAPA-W	FDA UDI	Class II	Active
Straight Pre-Made Abutment	A-MD-TS-EX230-5	FDA UDI	Class II	Active
Shelta Implant Zirti Regular	SH-ZT-380-115	FDA UDI	Class II	Active
Millable Titanium Abutment	A-TG-CAMTABU-M-CRE	FDA UDI	Class II	Active
Millable Titanium Abutment	E-CAMTABUF-330-08	FDA UDI	Class I	Active
Box For Pre-Made Abutment	PBOX-A-MDR-330-1-S	FDA UDI	Class I	Active
Bone Expander Violet For D.b.e	ESP-G-550	FDA UDI	Class I	Active
Cylindrical Final Drill	GS-F340-100-550	FDA UDI	Class I	Active
Pull-Up Transfer For Pre-Koh	A-TRARP-500	FDA UDI	Class II	Active
T-Connect For Single	AS-TC-UNI-425	FDA UDI	Class II	Active
Cylindrical Final Drill	GS-F280-115-415	FDA UDI	Class I	Active
Right Angle Bone Tap	E-MS-330-CA	FDA UDI	Class I	Active
Plain Abutment H3 Mm	A-PLAIN-ABU500-3	FDA UDI	Class II	Active
Plain Abutment H3 Mm	A-PLAIN-ABU-380C-3	FDA UDI	Class II	Active
Prama Rf Implant Zirti	LS-ZT-425SL-180	FDA UDI	Class II	Active
Premium Sp Implant Zirti	A-ZT-500SP-085	FDA UDI	Class II	Active
Preparation Drills Kit For Temporary Bridges For B.o.p.t.	Z4555	FDA UDI	Class I	Active
Countersink Drill D.4.10 Mm	FC-XS	FDA UDI	Class I	Active
Screw M2 For Rip.abutment	A-TG-VABUR-W-10	FDA UDI	Class II	Active
Right Angle Bone Tap	SH-MS-600-CA	FDA UDI	Class I	Active
Analogue For Abutment	SH-INT-CAMANA-425	FDA UDI	Class I	Active
T-Connect For Implants Bridges	L-TCIN-500-05-ROT	FDA UDI	Class II	Active
Straight Est. Pad Abut.	AS-PADE-AD425-15	FDA UDI	Class II	Active
Solid One-Piece Abutment	A-MDAD-425	FDA UDI	Class II	Active
Stop For Conical Syra Short	SE-STOP-FK500-060	FDA UDI	Class I	Active
Hand Screwdriver For Ball	BASCC-EX	FDA UDI	Class I	Active
Diamond Bur	FG863M/016C	FDA UDI	Class I	Active
Spare Cast. Sleeve For	TC-UNI-CC-S	FDA UDI	Class II	Active
Short Drill Diam. 4, 25 Mm	GS-F425-C	FDA UDI	Class I	Active
Transgingival Healing Cap H5mm	A-TMGR-425-5	FDA UDI	Class II	Active
Reply For Shelta Implant	SH-500-130-RP	FDA UDI	Class I	Active
Straight Pre-Made Abutment	A-MD-TS-330-05	FDA UDI	Class II	Active
T-Connect For Implants Bridges	PADR-TC-M-4	FDA UDI	Class II	Active

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