Question 1

What types of medical devices does Topdental (Products) Ltd manufacture?

Accepted Answer

Topdental (Products) Ltd specialises in lubricants and cleaning solutions for dental handpieces. Their product range includes universal handpiece oils, spray lubricants like tg lube and PoloDent, and enzymatic ultrasonic cleaners such as Unodent Enzymatic Ultrasonic Cleaner. They also produce detergents like Douromed, designed specifically for ultrasonic cleaning of dental instruments. These products are tailored to maintain and protect dental equipment during use and maintenance.

Question 2

Where is Topdental (Products) Ltd based?

Accepted Answer

Topdental (Products) Ltd is based in the United Kingdom (GB). This location is relevant for regulatory purposes, as it indicates the company’s operational headquarters and the jurisdiction under which its devices are authorised.

Question 3

Which regulatory registries list Topdental (Products) Ltd’s devices?

Accepted Answer

Topdental (Products) Ltd’s devices are listed in the eudamed database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU regulations, particularly for Class I devices like those produced by the company.

Question 4

How are Topdental (Products) Ltd’s devices classified under medical device regulations?

Accepted Answer

Topdental (Products) Ltd’s devices are classified as Class I medical devices. This classification is determined by their intended use—lubricants and cleaning solutions for dental handpieces—which poses minimal risk to patients and users. Class I devices typically undergo less stringent regulatory scrutiny than higher-risk categories but still require compliance with essential safety and performance requirements.

Device	Model / Reference	Registries	Class	Status
i-RANGE i-LUBE Universal Handpiece Oil	ILUB500	EUDAMED	Class I	Active
tg lube All Purpose Handpiece Lubricant Oil Spray	LUB01	EUDAMED	Class I	Active
PoloDent Universal Oil Spray	518600	EUDAMED	Class I	Active
Wrights Apex Universal Handpiece Oil	2S00519	EUDAMED	Class I	Active
Unodent Enzymatic Ultrasonic Cleaner	GUC000	EUDAMED	Class I	Active
Wrights UltraClean	2S03195	EUDAMED	Class I	Active
Bossklein UNIoil	BOS9777	EUDAMED	Class I	Active
Unodent Enzymatic Ultrasonic Cleaner	GUC005	EUDAMED	Class I	Active
Unodent Unolube Universal Handpiece Oil	GOU100	EUDAMED	Class I	Active
Crown Dental Supply Universal Handpiece Oil	107-001	EUDAMED	Class I	Active
Wrights UltraClean	2S03194	EUDAMED	Class I	Active
Douromed detergente de ultrasons	TD9788	EUDAMED	Class I	Active
ID Limpiador Ultrasonidos	DIB137	EUDAMED	Class I	Active
Topdental Universal Handpiece Oil	TOP0037	EUDAMED	Class I	Active
Precision Universal Handpiece Oil	L1500	EUDAMED	Class I	Active
Topdent Hygiene Enzymatic Ultrasonic Cleaner Concentrate	734343	EUDAMED	Class I	Active
CBM Ultrasonic Cleaner	CBM9788	EUDAMED	Class I	Active
Bossklein ULTRAbio	BOS9794	EUDAMED	Class I	Active
Bossklein ULTRAbio	BOS9788	EUDAMED	Class I	Active
Coltene Bioscience UC40	60021961	EUDAMED	Class I	Active
Crown Dental Supply Ultrasonic Cleaner	123-043	EUDAMED	Class I	Active
Precision Enzymatic Ultrasonic Cleaner Concentrate	40061L	EUDAMED	Class I	Active
Coltene Biosonic UC40	60021960	EUDAMED	Class I	Active
Crown Dental Supply Ultrasonic Cleaner	123-044	EUDAMED	Class I	Active
Douromed detergente de ultrasons	TD9794	EUDAMED	Class I	Active
Denka Fix Universal Handpiece Oil	D259	EUDAMED	Class I	Active
Douromed óleo lubrificante universal	TD9777	EUDAMED	Class I	Active
PoloDent Ultrasonic Cleaner Concentrate	830007	EUDAMED	Class I	Active
polydent Universal Handpiece Oil Spray	1899-001	EUDAMED	Class I	Active

Topdental (Products) Ltd

What Topdental (Products) Ltd makes

Frequently asked questions

Information

Catalogue (29)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities