Question 1

What types of medical devices does SDS Swiss Dental Solutions AG manufacture?

Accepted Answer

SDS Swiss Dental Solutions AG specializes in dental devices, specifically dental implant systems and dental osteotomes. The implant systems are designed to support dental prosthetics, while the osteotomes are surgical tools used to prepare bone sites for implant placement. These devices are tailored for dental professionals performing restorative procedures.

Question 2

Where is SDS Swiss Dental Solutions AG based?

Accepted Answer

The company is headquartered in Switzerland, which is a key location for medical device manufacturing due to its stringent regulatory environment and expertise in precision engineering. This base supports the development and production of its dental implant and osteotome devices.

Question 3

Which regulatory registries list SDS Swiss Dental Solutions AG’s devices?

Accepted Answer

SDS Swiss Dental Solutions AG’s devices are listed in multiple global regulatory databases, including the EU’s eudamed (EUDAQD), the FDA’s 510(k) clearance system, and the FDA’s Unique Device Identifier (UDI) database. These listings reflect compliance with EU and US regulatory requirements for medical devices.

Question 4

How are SDS Swiss Dental Solutions AG’s devices classified under EU regulations?

Accepted Answer

The company’s devices fall into different risk-based classifications under EU regulations: Class I (low-risk devices like some osteotomes), Class IIa and Class IIb (moderate- to higher-risk devices like certain implant systems), and Class IIb (for devices requiring additional scrutiny due to their surgical nature). Classification depends on factors like intended use, risk of harm, and patient contact duration.

Device	Model / Reference	Registries	Class	Status
ISO adapter	SDS_ITISO-ST	EUDAMEDFDA UDI	Class IIa	Active
SDS2.2 15° standard implant post	SDS2.2_AP-S15°	EUDAMEDFDA UDI	Class IIb	Active
Form drill D1- Ø6.7	SDSsd670C	EUDAMED	Class IIa	Active
Chirurgie Box neu leer	SDS00401	EUDAMEDFDA UDI	Class I	Active
Form drill D2- Ø3.8	SDSsd300rd	EUDAMEDFDA UDI	Class IIa	Active
Countersink drill D3- Ø5.4	SDS2.0_CS-600+	EUDAMEDFDA UDI	Class IIa	Active
SDS1.2 Insertion tool single-use	SDS1.2_ITscrew- ST_single-use	EUDAMED	Class IIa	Active
SDS2.2 Standard screw PEEK	SDS2.2_SS-P	EUDAMEDFDA UDI	Class IIa	Active
Screwdriver short	SDS-SD_short-ST	EUDAMEDFDA UDI	Class IIa	Active
Form drill D4- Ø5.4	SDSsd460dt	EUDAMEDFDA UDI	Class IIa	Active
BISS Zwickzange	BISS_TP	EUDAMED	Class I	Active
Countersink drill D4- Ø3.8	SDScs500	EUDAMEDFDA UDI	Class IIa	Active
Form drill D1- Ø3.8	SDSsd350C	EUDAMEDFDA UDI	Class IIa	Active
Pilot drill	SDSpd250	EUDAMEDFDA UDI	Class IIa	Active
Round bur	SDSrb230	EUDAMEDFDA UDI	Class IIa	Active
BISS Schraubendreher Griff	BISS_SDH	EUDAMED	Class I	Active
SDS2.2 standard implant post	SDS2.2_AP-S	EUDAMED	Class IIb	Active
BISS Turm Tray	BISS_TT-empty	EUDAMED	Class I	Active
SDS1.2 Standard screw titanium	SDS1.2_SS-T	EUDAMEDFDA UDI	Class IIa	Active
Screwdriver long	SDS-SD-ST	EUDAMEDFDA UDI	Class IIa	Active
Form drill D4- Ø4.6	SDSsd380dt	EUDAMEDFDA UDI	Class IIa	Active
BISS Starter Tray	BISS_ST-T1	EUDAMED	Class I	Active
Countersink drill D3- Ø3.8	SDS2.0_CS-500	EUDAMEDFDA UDI	Class IIa	Active
SDS2.2 standard implant post + 1.5 mm	SDS2.2_AP-S+1.5	EUDAMEDFDA UDI	Class IIb	Active
AIM2.2 Titanschraube	AIM2.2_SS-T	EUDAMED	Class I	Active
BISS Schraubendreher Einsatz	BISS_SDI	EUDAMED	Class I	Active
SDS2.2 Insertion tool single-use	SDS2.2_ITscrew-ST_single-use	EUDAMED	Class IIa	Active
Drill extension	SDSse001	EUDAMEDFDA UDI	Class IIa	Active
SDS2.2 Standard screw titanium	SDS2.2_SS-T	EUDAMED	Class IIa	Active
BISS Schraubendreher Einsatz mittel	BISS_SDI-M	EUDAMED	Class I	Active
AIM Pinzette	AIM_F	EUDAMED	Class I	Active
SDS1.2, 3.8 mm temporary cap	SDS1.2_PC_3.8-P	EUDAMEDFDA UDI	Class IIa	Active
Form drill D2- Ø4.6	SDSsd370rd	EUDAMEDFDA UDI	Class IIa	Active
BISS Osteo Tray	BISS_ST-T3	EUDAMEDFDA UDI	Class I	Active
Countersink drill D4- Ø4.6	SDScs600	EUDAMEDFDA UDI	Class IIa	Active
BISS Hammer	BISS_HAM	EUDAMEDFDA UDI	Class I	Active
BISS Profi Tray	BISS_ST-T2	EUDAMED	Class I	Active
Einbringtool Entferner	SDS_ITR	EUDAMED	Class I	Active
Form drill D1- Ø5.4	SDSsd510C	EUDAMEDFDA UDI	Class IIa	Active
SDS1.2, 4.6 mm temporary cap	SDS1.2_PC_4.6-P	EUDAMEDFDA UDI	Class IIa	Active
SDS Chirurgie Box klein leer	SDS00402	EUDAMED	Class I	Active
Form drill D4- Ø3.8	SDSsd300dt	EUDAMEDFDA UDI	Class IIa	Active
Countersink drill D3- Ø4.6	SDS2.0_CS-600	EUDAMEDFDA UDI	Class IIa	Active
AIM1.2 Titanschraube	AIM1.2_SS-T	EUDAMED	Class I	Active

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