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	SRA-C4800-15	FDA UDI	Class II	Active
Ditron Dental	TMUA-200350	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	UPC-42014	FDA UDI	Class II	Active
Ditron Dental	TD500L16C	FDA UDI	Class I	Active
Ditron Dental	APC-37512	FDA UDI	Class II	Active
Ditron Dental	CPC-37516	FDA UDI	Class II	Active
Ditron Dental	UMU-0330	FDA UDI	Class II	Active
Ditron Dental	CMUA-3045	FDA UDI	Class II	Active
Ditron Dental	LIB-CC50	FDA UDI	Class II	Active
Ditron Dental	TRS-3060	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TLI-HC550	FDA UDI	Class II	Active
Ditron Dental	HCC-3545	FDA UDI	Class II	Active
Ditron Dental	TLI-LIB40	FDA UDI	Class II	Active
Ditron Dental	CAS-C10ST	EUDAMEDFDA UDI	Class II	Active
Ditron Dental	THKL-200300	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TD550L16C	FDA UDI	Class I	Active
Ditron Dental	FSBOX-001C	FDA UDI	Class I	Active
Ditron Dental	CPC-37511	FDA UDI	Class II	Active
Ditron Dental	DGS-IM120	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	MPC-42010	FDA UDI	Class II	Active
Ditron Dental	CAP-H3015	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	CPC-50010	FDA UDI	Class II	Active
Ditron Dental	CAT-C10ST	FDA UDI	Class II	Unknown
Ditron Dental	ANT-C4525-08	FDA UDI	Class II	Active
Ditron Dental	APC-60014	FDA UDI	Class II	Active
Ditron Dental	APC-50011	FDA UDI	Class II	Active
Ditron Dental	SRA-SC3001	FDA UDI	Class II	Active
Ditron Dental	TTP-C6055	FDA UDI	Class II	Active
Ditron Dental	TLI-TBS310	FDA UDI	Class II	Active
Ditron Dental	TPP-200330	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	CRC-3000	FDA UDI	Class II	Active
Ditron Dental	SCR-3011	FDA UDI	Class I	Active
Ditron Dental	PD200L11.5SC	FDA UDI	Class I	Active
Ditron Dental	TMAL-200260	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TTP-C6045	FDA UDI	Class II	Active
Ditron Dental	MPC-37512	FDA UDI	Class II	Active
Ditron Dental	UPC-50012	FDA UDI	Class II	Active
Ditron Dental	APC-42008	FDA UDI	Class II	Active
Ditron Dental	UPC-60012	FDA UDI	Class II	Active
Ditron Dental	TRO-C3010	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TLI-LIB30	FDA UDI	Class II	Active
Ditron Dental	BAL-10005	FDA UDI	Class II	Active
Ditron Dental	APC-37514	FDA UDI	Class II	Active
Ditron Dental	CAP-H30ST	EUDAMEDFDA UDI	Class II	Active
Ditron Dental	UPC-60016	FDA UDI	Class II	Active
Ditron Dental	TTP-C4555	FDA UDI	Class II	Active
Ditron Dental	ASMD-300100	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	APC-50016	FDA UDI	Class II	Active
Ditron Dental	LIB-25CAP	FDA UDI	Class I	Active
Ditron Dental	UPC-37507	FDA UDI	Class II	Active

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