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	STOP3-200-070	FDA UDI	Class I	Active
Cylindrical Drill	FP-200-L-SW	FDA UDI	Class I	Active
Millable Titanium Abutment	A-CAMTABUF-425-12	FDA UDI	Class I	Active
17gr Angled Pad Abut., H5 Mm	AS-PAD-AA500-175	FDA UDI	Class II	Active
Cast. Non Rep. Post With Cr-Co	PAD-UCRCO	FDA UDI	Class II	Active
Locator Replacement Male,	8524	FDA UDI	Class II	Active
T-Connect For Implants Bridges	A-TCR-M-380-6-2	FDA UDI	Class II	Active
Millable Titanium Abutment	U-CAMTABUF-480-12	FDA UDI	Class I	Active
Stop For Conical Syra Short	SE-STOP-FK410-060	FDA UDI	Class I	Active
Brush	260/015CAXL	FDA UDI	Class I	Active
Premium One Implant Zirti	AS-ZT-500-130	FDA UDI	Class II	Active
Straight Pad Abutment, H4 Mm	A-PAD-AD425-40	FDA UDI	Class II	Active
Supplementary Drills Set	GS-PROS-INTEGRA-050	FDA UDI	Class I	Active
Pre-Made Rep. Abut Anatomical	A-MDR-380-1-S	FDA UDI	Class I	Active
Intermediate Drill	GS-F250-050-415	FDA UDI	Class I	Active
Supplementary Drills Set	GS-50-L-FSTN-INTEGRA	FDA UDI	Class I	Active
T-Connect For Single	L-TCIN-500-10	FDA UDI	Class II	Active
Curved Handle	FLU-M-C	FDA UDI	Class I	Active
Round Tip Osteotome For Global	OS-U-380-115-PT	FDA UDI	Class I	Active
Parallel Pin	PP-2/28	FDA UDI	Class I	Active
Healing Cap For Pre-Made Abut	AS-CAP-CG-MDR-425-1	FDA UDI	Class I	Active
Prosthetic Box For Xa Post	PBOX-SHXA-380-2	FDA UDI	Class II	Active
17gr Angled Pad Abut., H5 Mm	AS-PAD-AA425-175	FDA UDI	Class II	Active
T-Connect For Single	A-TC-UNI-330-2-ROT	FDA UDI	Class II	Active
Gold Pins U Profile For Round	CAV-375	FDA UDI	Class II	Active
Premium One Implant Zirti	AS-ZT-500-150	FDA UDI	Class II	Active
T-Connect For Single	A-TG-BASTZR-S-M	FDA UDI	Class II	Active
Easy Mounter	GS-EASYPE-L-415-EX	FDA UDI	Class I	Active
Analogue For Implant	A-TG-ANA-W	FDA UDI	Class II	Active
Global Bone Expander Kit	OS-U-KIT-INT	FDA UDI	Class II	Active
Ball Attachment Impl. Pre/Koh	A-AS-380-2	FDA UDI	Class II	Active
T-Connect For Implants Bridges	PADR-TC-M-8	FDA UDI	Class II	Active
Locator Abutment Pre/Koh 4.25	1681	FDA UDI	Class II	Active
Analogue For Pre-Made	AS-ANA-MDR-425-2-S	FDA UDI	Class I	Active
Countersink For Outlink2	GS-FC-E375	FDA UDI	Class I	Active
Intermediate Drill	GS-F2030-550	FDA UDI	Class I	Active
Drill	GS-F250-130-50	FDA UDI	Class I	Active
17gr Angled Pad Abut., H3 Mm	AS-PAD-AA425-173	FDA UDI	Class II	Active
T-Connect For Single	AS-TC-UNI-425-1	FDA UDI	Class II	Active
Drill	GS-F200-180-50	FDA UDI	Class I	Active
Ball Attachment Impl. Pre/Koh	A-AS-425-4	FDA UDI	Class II	Active
Box For Pre-Made Abutment	PBOX-A-MDR-380-2	FDA UDI	Class I	Active
Stop For Short Drill	STOPS4-300-070	FDA UDI	Class I	Active
Final Cylindrical Drill	FFT3-340-LXS	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP4-425-070	FDA UDI	Class I	Active
17gr Ang. Est. Pad Abut.	A-PADE-AA380-175	FDA UDI	Class II	Active
Round Tip Osteotome For Global	OS-U-430-115-PT	FDA UDI	Class I	Active
Millable Titanium Abutment	A-CAMTABUF-330-12	FDA UDI	Class I	Active
Prama Rf White Implant Zirti	LSLW-ZT-500-060	FDA UDI	Class II	Active
Final Conical Drill Shelta	SH-FK425-085	FDA UDI	Class I	Active

SWEDEN & MARTINA INC

What SWEDEN & MARTINA INC makes

Frequently asked questions

Information

Catalogue (2631)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities