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	UPC-35013	FDA UDI	Class II	Active
Ditron Dental	TLI-50010	FDA UDI	Class II	Active
Ditron Dental	MPC-35012	FDA UDI	Class II	Active
Ditron Dental	ABT-C3515-15	FDA UDI	Class II	Active
Ditron Dental	APC-35013	FDA UDI	Class II	Active
Ditron Dental	MUSB-4807	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	CPC-35014	FDA UDI	Class II	Active
Ditron Dental	TTP-C4515	FDA UDI	Class II	Active
Ditron Dental	ANT-C4515-25	FDA UDI	Class II	Active
Ditron Dental	LIB-PACK/D	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	PCT1	FDA UDI	Class I	Active
Ditron Dental	MPC-35010	FDA UDI	Class II	Active
Ditron Dental	APC-37513	FDA UDI	Class II	Active
Ditron Dental	UPC-35008	FDA UDI	Class II	Active
Ditron Dental	THSS-200210	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	DISKit-C	FDA UDI	Class I	Active
Ditron Dental	CMUA-1715	FDA UDI	Class II	Active
Ditron Dental	CPC-37513	FDA UDI	Class II	Active
Ditron Dental	TBHX-8230-06	FDA UDI	Class II	Unknown
Ditron Dental	APC-60011	FDA UDI	Class II	Active
Ditron Dental	UPC-37510	FDA UDI	Class II	Active
Ditron Dental	CPC-60011	FDA UDI	Class II	Active
Ditron Dental	THRL-200301	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	UMU-30ST	FDA UDI	Class II	Active
Ditron Dental	TBS-200400	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	APC-35010	FDA UDI	Class II	Active
Ditron Dental	MPI-16600	FDA UDI	Class II	Unknown
Ditron Dental	TTI-C3500-45	FDA UDI	Class II	Active
Ditron Dental	SBDY-8200	FDA UDI	Class I	Active
Ditron Dental	LIB-ABT60	FDA UDI	Class II	Active
Ditron Dental	SCR-3010	FDA UDI	Class I	Active
Ditron Dental	ABT-C4500-15	FDA UDI	Class II	Active
Ditron Dental	PD200L8SC	FDA UDI	Class I	Active
Ditron Dental	UPC-60007	FDA UDI	Class II	Active
Ditron Dental	APC-60065	FDA UDI	Class II	Active
Ditron Dental	ANT-C4500-45	FDA UDI	Class II	Active
Ditron Dental	TLI-IDS410	FDA UDI	Class I	Active
Ditron Dental	THKS-200290	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	RW-200311	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	APC-37516	FDA UDI	Class II	Active
Ditron Dental	LIB-25RND	FDA UDI	Class I	Active
Ditron Dental	TLI-42013	FDA UDI	Class II	Active
Ditron Dental	APC-50014	FDA UDI	Class II	Active
Ditron Dental	APC-35008	FDA UDI	Class II	Active
Ditron Dental	DGS-FPH100	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	TLI-LIB20	FDA UDI	Class II	Active
Ditron Dental	TLI-37516	FDA UDI	Class II	Active
Ditron Dental	TMAL-200280	EUDAMEDFDA UDI	Class I	Active
Ditron Dental	ANT-C4515-45	FDA UDI	Class II	Active
Ditron Dental	TLI-TB350	FDA UDI	Class II	Active

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