Question 1

What types of medical devices does Ditron Dental Ltd manufacture?

Accepted Answer

Ditron Dental Ltd specializes in dental implantology and related procedures. Their product range includes screw endosteal dental implants (both one- and two-piece designs), reusable surgical kits for dental/maxillofacial procedures, and preformed dental implant suprastructures—both permanent and temporary single-use versions. They also produce reusable dental drill bits, dental implant analogs, abutment screws, guided sleeves, anchoring screws, and prosthetic screwdrivers. These devices support implant placement, restoration, and prosthetic fitting in dental treatments.

Question 2

Where is Ditron Dental Ltd based, and what is its primary focus?

Accepted Answer

Ditron Dental Ltd is based in Israel. The company’s focus is on developing and manufacturing dental implant systems and associated tools. Their devices are designed to assist in dental implantology, including implant placement, surgical procedures, and prosthetic restoration, catering to both clinical and laboratory settings.

Question 3

Which regulatory registries list Ditron Dental Ltd’s devices?

Accepted Answer

Ditron Dental Ltd’s devices are listed in the EUDAMED database under the EU Medical Device Regulations, and their products are also registered in the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for authorized devices in their respective markets.

Question 4

How are Ditron Dental Ltd’s devices classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulations, Ditron Dental Ltd’s devices fall into two classification categories: Class I and Class II. The classification depends on factors like the intended use, risk associated with the device, and its interaction with the patient. For example, dental implant suprastructures and surgical kits may be classified as Class II due to their higher risk profile compared to simpler tools like reusable drill bits, which might fall under Class I.

Question 5

What distinguishes Ditron Dental Ltd’s dental implant systems from other manufacturers?

Accepted Answer

Ditron Dental Ltd’s portfolio includes a combination of implant fixtures, surgical tools, and prosthetic components tailored for precision in dental restoration. Their offerings span both reusable and single-use items, such as guided sleeves for implant placement and temporary/single-use suprastructures, which cater to different clinical workflows. The inclusion of analogs and abutment screws also supports comprehensive implant treatment planning, from initial placement to final prosthetic fitting.

Device	Model / Reference	Registries	Class	Status
Ditron Dental	TLI-50008	FDA UDI	Class II	Active
Ditron Dental	CPI-08350	FDA UDI	Class II	Unknown
Ditron Dental	CPI-08330	FDA UDI	Class II	Unknown
Ditron Dental	CPC-50065	FDA UDI	Class II	Active
Ditron Dental	CPI-06500	FDA UDI	Class II	Unknown
Ditron Dental	TTI-C3501-08	FDA UDI	Class II	Active
Ditron Dental	TD250L10SC	FDA UDI	Class I	Active
Ditron Dental	TRC-C3022	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TD450L13SC	FDA UDI	Class I	Active
Ditron Dental	TTI-C3501-45	FDA UDI	Class II	Active
Ditron Dental	TLI-33013	FDA UDI	Class II	Active
Ditron Dental	SCR-3030	FDA UDI	Class I	Active
Ditron Dental	CPC-42008	FDA UDI	Class II	Active
Ditron Dental	UMU-0317	FDA UDI	Class II	Active
Ditron Dental	TTI-C3501-15	FDA UDI	Class II	Active
Ditron Dental	TLI-37511	FDA UDI	Class II	Active
Ditron Dental	TD450L11.5SC	FDA UDI	Class I	Active
Ditron Dental	CAS-H10ST	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TLI-ID400	FDA UDI	Class I	Active
Ditron Dental	TTI-C4501-08	FDA UDI	Class II	Active
Ditron Dental	CAP-H2015	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	SRA-TT4800	FDA UDI	Class II	Active
Ditron Dental	TLI-50013	FDA UDI	Class II	Active
Ditron Dental	TLI-35010	FDA UDI	Class II	Active
Ditron Dental	CAP-H2025	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	APC-42016	FDA UDI	Class II	Active
Ditron Dental	CRC-3015	FDA UDI	Class II	Active
Ditron Dental	CAC-C10ST	FDA UDI	Class II	Unknown
Non-Sterile Dental Abutment	SRA-8025	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	API-11375	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	CPI-08500	EUDAMEDFDA UDI	Class IIb	Active
Drill with Integral Stopper	DRIS-280L13	EUDAMEDFDA UDI	Class IIa	Active
Non-Sterile Dental Abutment	BLKT-8220-12	EUDAMEDFDA UDI	Class IIb	Active
Drill with Integral Stopper	DRIS-280L6	EUDAMEDFDA UDI	Class IIa	Active
Trephine Burr Drill	DRTB-303040	EUDAMEDFDA UDI	Class IIa	Active
Drill with Integral Stopper	DRIS-320L6	EUDAMEDFDA UDI	Class IIa	Active
Non-Sterile Dental Abutment	LIB-ABT05	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	LIB-ABT30	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	MPI-13420	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	ABT-5015-1	EUDAMEDFDA UDI	Class IIb	Active
Drill with Integral Stopper	DPIS-200L10	EUDAMEDFDA UDI	Class IIa	Active
Non-Sterile Dental Abutment	TAB-7001	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	API-13500	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	ULT-07375	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	MPI-11375	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	MUA-10ST	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	TBCL-8231-06	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	ABT-6040	EUDAMEDFDA UDI	Class IIb	Active
Non-Sterile Dental Abutment	MUS-9150	EUDAMEDFDA UDI	Class IIb	Active
Sterile Dental Implant	API-08350	EUDAMEDFDA UDI	Class IIb	Active

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