Question 1

What types of medical devices does A.B. Dental Devices Ltd manufacture?

Accepted Answer

A.B. Dental Devices Ltd specializes in dental instruments, specifically reusable surgical screwdrivers and a variety of dental drills. These include coated step drills, coated drills, and straight drills (uncoated), all designed for dental procedures. The company focuses on tools used in implantology and restorative dentistry.

Question 2

Where is A.B. Dental Devices Ltd based?

Accepted Answer

A.B. Dental Devices Ltd is based in Israel. The company’s headquarters and manufacturing operations are located within the country, though its products are marketed internationally.

Question 3

Which regulatory registries list A.B. Dental Devices Ltd’s devices?

Accepted Answer

A.B. Dental Devices Ltd’s devices are listed in the EUDAMED registry, which is the European database for medical devices. This registry tracks devices that have undergone regulatory procedures under EU regulations, such as classification and conformity assessments.

Question 4

How are A.B. Dental Devices Ltd’s devices classified under EU regulations?

Accepted Answer

A.B. Dental Devices Ltd’s devices are classified as either Class I or Class IIa under EU medical device regulations. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, dental instruments like screwdrivers and drills are typically lower-risk and fall into Class I, while some specialized tools may require additional scrutiny, placing them in Class IIa.

Question 5

Why are some of A.B. Dental Devices Ltd’s dental drills coated while others are not?

Accepted Answer

The coating on dental drills (such as coated step drills or coated drills) is often applied to enhance performance, durability, or infection control. Coatings can reduce friction, extend tool lifespan, or provide antimicrobial properties, which is particularly useful in sterile dental environments. Straight drills that are uncoated may be designed for specific procedures where coating isn’t necessary or could interfere with functionality. The choice depends on clinical requirements and regulatory considerations.

Device	Model / Reference	Registries	Class	Status
Class I - Dental Instruments	TR-3-1.5	EUDAMED	Class I	Active
Class I - Dental Instruments	T3GS-2.0,11	EUDAMED	Class I	Active
Coated Step Drills	TDSD-5.5	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T3GS-2.4,13	EUDAMED	Class I	Active
Class I - Dental Instruments	T3GS-2.0,13	EUDAMED	Class I	Active
Class I - Dental Instruments	P24-aL	EUDAMED	Class I	Active
Class I - Dental Instruments	TR-5.1-4.5-R	EUDAMED	Class I	Active
Straight Drills (Not Coated)	T5-Trx,20	EUDAMED	Class IIa	Active
Class I - Dental Instruments	P14,SC	EUDAMED	Class I	Active
Class I - Dental Instruments	P64-bT-D2	EUDAMED	Class I	Active
Coated Drills	TDGT-4.0,16	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T3C-4,18	EUDAMED	Class I	Active
Class I - Dental Instruments	T8c-10-40Q	EUDAMED	Class I	Active
Class I - Dental Instruments	T4C-4	EUDAMED	Class I	Active
Coated Step Drills	TKDC	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T1-Trx,15	EUDAMED	Class I	Active
Class I - Dental Instruments	P14C-aL	EUDAMED	Class I	Active
Class I - Dental Instruments	T3GS-2.0,15	EUDAMED	Class I	Active
72911127CADfIFV	Tango-I2-3.75,13	EUDAMED	Class IIa	Active
Coated Drills	TDGT-2.5,6	EUDAMED	Class IIa	Active
Coated Drills	TDGT-2.5,11.5	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T10-SBC	EUDAMED	Class I	Active
Coated Step Drills	TKM-T8C-SD-CP	EUDAMED	Class IIa	Active
72911127CADfIFV	T5C-4,25	EUDAMED	Class IIa	Active
Class I - Dental Instruments	P24N-12,SC	EUDAMED	Class I	Active
Coated Drills	TDGT-2.5,16	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T4-3	EUDAMED	Class I	Active
72911127CADfIFV	FS-13	EUDAMED	Class IIa	Active
Class I - Dental Instruments	TRS-5.1-4.5-R	EUDAMED	Class I	Active
Coated Drills	TDGT-4.0,6	EUDAMED	Class IIa	Active
Coated Drills	TDGP-2.2,4.7	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T13	EUDAMED	Class I	Active
Class I - Dental Instruments	PBMP-SP	EUDAMED	Class I	Active
Class I - Dental Instruments	TP-1.5,31	EUDAMED	Class I	Active
Class I - Dental Instruments	P2NH-3,15	EUDAMED	Class I	Active
Class I - Dental Instruments	D2OCal-4	EUDAMED	Class I	Active
Coated Drills	TDL-2.3,40	EUDAMED	Class IIa	Active
Class I - Dental Instruments	T3GSa-2.4,15	EUDAMED	Class I	Active
Coated Drills	TDGT-2.8,8	EUDAMED	Class IIa	Active
Class I - Dental Instruments	TSE-FG	EUDAMED	Class I	Active
Class I - Dental Instruments	PK-D2S	EUDAMED	Class I	Active
Coated Step Drills	TDZ-2,60	EUDAMED	Class IIa	Active
Class I - Dental Instruments	D2-P14C-AR	EUDAMED	Class I	Active
Class I - Dental Instruments	T3GS-2.4,15	EUDAMED	Class I	Active
Class I - Dental Instruments	D1-P24N,MA	EUDAMED	Class I	Active
Contra Angle Drivers for Abutment	T20-P,25	EUDAMED	Class IIa	Active
Coated Step Drills	TDSD-2.5	EUDAMED	Class IIa	Active
Coated Drills	TDGT-3.2,11.5	EUDAMED	Class IIa	Active
Class I - Dental Instruments	P64,SC	EUDAMED	Class I	Active
Class I - Dental Instruments	TD-T17-4.35	EUDAMED	Class I	Active

A.B. Dental Devices Ltd

About

What A.B. Dental Devices Ltd makes

Frequently asked questions

Information

Catalogue (199)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities