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
Healing Cap For	PADR-CG	FDA UDI	Class II	Active
Analogue For Pre-Made	A-ANA-MD-330-S	FDA UDI	Class I	Active
Temp. Cap For Pre-Made Abut	A-CAP-PRO-MD-330-S	FDA UDI	Class I	Active
Drill	GS-F250-200-50	FDA UDI	Class I	Active
T-Connect For Single	AS-BASTZR-S-425-4	FDA UDI	Class II	Active
Cast. Non Rep. Post With Gold	A-TG-UC-W-ROT	FDA UDI	Class II	Active
Block-Out Spacer	8514	FDA UDI	Class II	Active
Intermediate Drill	GS-F200-100-550	FDA UDI	Class I	Active
Prosthetic Accessories Kit	ZPA001E01	FDA UDI	Class II	Active
Prama White Implant Zirti	LAW-ZT-380-100	FDA UDI	Class II	Active
T-Connect For Single	L-TCIN.-380-10	FDA UDI	Class II	Active
T-Connect For Single	PADR-TC-S-8	FDA UDI	Class II	Active
Pre/Koh Bone Profiler	A-PAD-PS500-S	FDA UDI	Class I	Active
Shelta Implant Zirti Wide	SH-ZT-425SL-115	FDA UDI	Class II	Active
Straight Est. Pad Abut.	A-PADE-AD380-40	FDA UDI	Class II	Active
Premium Straight Implant Zirti	A-ZT-425-150	FDA UDI	Class II	Active
T-Connect For Single Crown	A-TCR-S-380-6-3	FDA UDI	Class II	Active
Short Hand Bone Tap	A-MSC-600	FDA UDI	Class I	Active
Intraoral Scanbody	L-INT-CAMTRA-L	FDA UDI	Class I	Active
Stop For Conical Drill	STOP-2025-260-SW	FDA UDI	Class I	Active
Spare Cast. Sleeve For	A-CCI-M	FDA UDI	Class II	Active
Plain Abutment H4 Mm	A-PLAIN-ABU425-4	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP4-200-085	FDA UDI	Class I	Active
Cylindrical Final Drill	GS-F340-115-550	FDA UDI	Class I	Active
Millable Crco Abutment	U-CAMCABUF-430-12	FDA UDI	Class I	Active
Straight Pre-Made Abutment	A-MD-TS-EX250-05	FDA UDI	Class II	Active
Cast. Non Rep. Post With Crco	A-UCRCO-425	FDA UDI	Class II	Active
Screw For Abutment Transfer	A-VTRABU-180	FDA UDI	Class II	Active
T-Connect For Single	A-TC-UNI-330-3-ROT	FDA UDI	Class II	Active
Initial Drill Built-In Stop	GS-F200-550	FDA UDI	Class I	Active
Transgingival Healing Cap H2mm	A-TMG-380-2	FDA UDI	Class II	Active
Intermediate Drill	FG-330/425XS	FDA UDI	Class I	Active
Analogue For Pre-Made	A-ANA-MDR-380-2	FDA UDI	Class I	Active
Pre-Made Non Rep. Post For	L-MDT-340-10-ROT	FDA UDI	Class II	Active
Cylindrical Final Drill	GS-F300-130-415	FDA UDI	Class I	Active
Tapered Final Drill	GS-FK500-050-550	FDA UDI	Class I	Active
Non Rep. Cast.sleeve For Abut.	A-TG-CCABU-W-ROT	FDA UDI	Class II	Active
Stop For Cylindrical Drill	STOP4-340-085	FDA UDI	Class I	Active
30gr Ang. Est. Pad Abut.	A-PADE-AA330-305	FDA UDI	Class II	Active
Healing Cap For Pre-Made Abut	AS-CAP-CG-MD-500	FDA UDI	Class I	Active
Stop For Cylindrical Drill	STOP3-300-100	FDA UDI	Class I	Active
Spare Cast. Sleeve For	A-CCABU-425-ROT	FDA UDI	Class II	Active
Hand Driver For R.a. Instrum.	AVV-CA-DG-EX	FDA UDI	Class I	Active
X-Ray Templates	U2-L100	FDA UDI	Class I	Active
Long Drill Diam. 3, 20 Mm	GS-F320-L	FDA UDI	Class I	Active
Break Up Drill D. 3.00 Mm	KM-F-B300	FDA UDI	Class I	Active
Right Angle Screwdriver For	L-HSM-CA	FDA UDI	Class I	Active
Red. Pad Abutment Screw	PADR-VM-180-10	FDA UDI	Class II	Active
Simple Temp. Post Tit. Non Rep	AS-MPSCI-425	FDA UDI	Class II	Active
Intraoral Scanbody	XA-INT-CAMTRA-L	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