Question 1

What types of medical devices does Novodent SA manufacture?

Accepted Answer

Novodent SA specializes in dental medical devices, including reusable surgical screwdrivers for dental procedures, preformed permanent suprastructures for dental implants, and dental implant abutment analogs designed for laboratory use. Their portfolio also covers drill bit extensions for precision drilling and dental implant suprastructure kits. Examples include the Bone Level Multi Unit Angled Abutment, Mono Implant Regular Smooth-Large Abutment, and the Implantswiss line of implant systems.

Question 2

Where is Novodent SA based, and what is its primary focus?

Accepted Answer

Novodent SA is based in Switzerland. The company focuses on developing and manufacturing dental implant-related devices, such as abutments, suprastructures, and tools used in dental implantology. Their offerings cater to both clinical and laboratory settings, ensuring precision and compatibility with implant systems.

Question 3

Which regulatory registries list Novodent SA’s devices?

Accepted Answer

Novodent SA’s devices are listed in the EUDAMED database under the EU Medical Device Regulations framework. Additionally, their products appear in the FDA’s 510(k) premarket notification and UDI (Unique Device Identification) registries in the United States, reflecting their compliance with both EU and US regulatory requirements.

Question 4

How are Novodent SA’s devices classified under medical device regulations?

Accepted Answer

Novodent SA’s devices fall under various classifications within the EU Medical Device Regulations, including Class I (low-risk devices), Class IIa (moderate-risk devices with special controls), and Class IIb (higher-risk devices requiring stringent scrutiny). The classification depends on factors like the device’s intended use, potential risks, and interaction with patients, ensuring appropriate regulatory oversight.

Question 5

What distinguishes Novodent SA’s dental implant devices from others in the market?

Accepted Answer

Novodent SA’s devices are designed with a focus on precision and compatibility within dental implant systems, such as their preformed suprastructures and abutment analogs. For example, their Bone Level Multi Unit Angled Abutment and Mono Implant Regular Smooth-Large Abutment are tailored for specific clinical needs, while their reusable surgical screwdrivers and drill bit extensions enhance procedural efficiency. The company’s offerings span both clinical and laboratory use, addressing multiple stages of dental implantology.

Device	Model / Reference	Registries	Class	Status
Implantswiss	S-BMUAICPGPin	FDA UDI	Class I	Unknown
Implantswiss	S-TFDMS	FDA UDI	Class I	Active
Implantswiss	S-BMFDMS	FDA UDI	Class I	Active
Implantswiss	S-IBClip-y	FDA UDI	Class I	Active
Implantswiss	S-BICTN65L	FDA UDI	Class I	Unknown
Implantswiss	S-BMUA48251	FDA UDI	Class II	Unknown
Implantswiss	S-12HDRS	FDA UDI	Class I	Active
Implantswiss	S-BMSAPIC37c	FDA UDI	Class I	Unknown
Implantswiss	S-BICTGL	FDA UDI	Class I	Unknown
Implantswiss	S-DP4.3	FDA UDI	Class I	Active
Implantswiss	S-BICT55S	FDA UDI	Class I	Unknown
Implantswiss	S-BFDML	FDA UDI	Class I	Active
Implantswiss	S-BMUA48251	FDA UDI	Class II	Active
Implantswiss	S-TOAPICy	FDA UDI	Class I	Unknown
Implantswiss	S-BMFDRL	FDA UDI	Class I	Active
Implantswiss	S-BFDRS	FDA UDI	Class I	Active
Implantswiss	S-BMFDML	FDA UDI	Class I	Active
i-LiNQ Connect Premill Scan Body Short	I-SILCOPSBS	EUDAMED	Class I	Active
Bone Level Couple Abutment Non-Hex	S-BCAN45407	EUDAMED	Class IIb	Active
Bone Level Impression Post	S-BIP45	EUDAMEDFDA UDI	Class I	Active
Bone Level Narrow Couple Abutment	S-BNCA35407	EUDAMED	Class IIb	Active
Bone Level O-Ring Abutment	S-BORA10	EUDAMEDFDA UDI	Class IIb	Active
i-system Multi Unit Abutment Plastic Cylinder Non-Hex	I-SMUAPICyN	EUDAMED	Class I	Active
Tissue Level Closing-Screw Small	S-TCISS	EUDAMEDFDA UDI	Class IIb	Active
i-system Healing Abutment	I-SHA5065(3)	EUDAMED	Class IIb	Active
Bone Level Mini Fixture Straight	S-BMFSR3312	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Scan Body Short	S-TSBS	EUDAMED	Class I	Active
Straight Drill	S-SD2806	EUDAMED	Class IIa	Active
Bone Level Couple Abutment	S-BCA45207	EUDAMEDFDA UDI	Class IIb	Active
Octa Abutment Driver Short	S-OADS	EUDAMEDFDA UDI	Class I	Active
Premill Octa Scan Body Short	S-POSBS	EUDAMED	Class I	Active
i-system Fixture	I-SF6005(3)	EUDAMED	Class IIb	Active
Mono Implant Regular Rough	MR4112-B	EUDAMED	Class IIb	Active
Bone Level Couple Abutment	S-BCA55207	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR3710	EUDAMEDFDA UDI	Class IIb	Active
Tissue Level Fixture Hybrid	S-TFHR4310	EUDAMEDFDA UDI	Class IIb	Active
Bone Level Abutment Screw	S-BAS	EUDAMEDFDA UDI	Class IIb	Active
i-LiNQ Mono Fixture	I-MF2708	EUDAMED	Class IIb	Active
I-LiNQ Impression Post	I-SILIP65	EUDAMED	Class I	Active
i-system Non- Shouldered Abutment	I-SNSA3050(2)	EUDAMED	Class IIb	Active
Bone Level Solid Abutment Impression Cap	S-BSAICap55	EUDAMEDFDA UDI	Class I	Active
Mono Implant Burnout Cap Large	MBC-LAb	EUDAMED	Class I	Active
i-LiNQ connect Abutments	I-SILCOR-35	EUDAMED	Class IIb	Active
Round Drill	S-RD	EUDAMED	Class IIa	Active
Hex Ratchet Driver Extra Large	S-12HDRXL	EUDAMEDFDA UDI	Class I	Active
i-system Non- Shouldered Abutment	I-SNSA5065(3)	EUDAMED	Class IIb	Active
Mono Implant Smooth -Micro	MSM3529- LAb	EUDAMED	Class IIb	Active
Tissue Level Couple Abutment	S-TCA20	EUDAMEDFDA UDI	Class IIb	Active
Zygoma Drill Guard	S-ZDG	EUDAMED	Class I	Active
I-Cement Abutment	I-SILCE50R	EUDAMED	Class IIb	Active

Novodent SA

What Novodent SA makes

Frequently asked questions

Information

Catalogue (1170)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities