Public Access Database for Medical Device Registration

Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA)
Where a conformity assessment certificate is listed as expired, existing products already placed on the market prior to the expiry may not be affected by this expiry and can continue to be used. This expiry stops new products being placed on the market until there is a new certificate of conformity

Manufacturer's By Name

By Device

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Manufacturer's Devices - Promedica Dental Material GmbH

Address:

Domagkstrasse 31

Neumuenster

Schleswig-Holstein 24537

Germany

Authorised Representative/ UK Responsible Person
Name: VINTUK REGULATORY SERVICES LTD
Address:

170 Edmund Street

Birmingham

B3 2HB

England United Kingdom

Code/Term Type

Denture repair kit professional Denture repair kit professional Class IIa

Calcium hydroxide dental cement Calcium hydroxide dental cement Class IIa

Glass ionomer dental cement Glass ionomer dental cement Class IIa

Dental unfilled resin sealant/coating Dental unfilled resin sealant/coating Class IIa

Temporary dental crown/bridge Temporary dental crown/bridge Class IIa

Dental base plate Dental base plate Class I

Dental etching solution Dental etching solution Class IIa

Dentine bonding agent/set Dentine bonding agent/set Class IIa

Dental composite resin Dental composite resin Class IIa

Pin/post dental drill bit Pin/post dental drill bit Class IIa

Fatty acid dental cement Fatty acid dental cement Class IIa

Dental material mixing nozzle Dental material mixing nozzle Class I

Dental material injection cannula single-use Dental material injection cannula single-use Class I

Dental material cartridge-plunging applicator two-component manual Dental material cartridge-plunging applicator two-component manual Class I

Contact details

Freedom of information

0203 080 7272 (manned 10:00-16:00 hours working days) device.registrations@mhra.gov.uk

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Code/Term		Type
Denture repair kit professional	Denture repair kit professional	Class IIa
Calcium hydroxide dental cement	Calcium hydroxide dental cement	Class IIa
Glass ionomer dental cement	Glass ionomer dental cement	Class IIa
Dental unfilled resin sealant/coating	Dental unfilled resin sealant/coating	Class IIa
Temporary dental crown/bridge	Temporary dental crown/bridge	Class IIa
Dental base plate	Dental base plate	Class I
Dental etching solution	Dental etching solution	Class IIa
Dentine bonding agent/set	Dentine bonding agent/set	Class IIa
Dental composite resin	Dental composite resin	Class IIa
Pin/post dental drill bit	Pin/post dental drill bit	Class IIa
Fatty acid dental cement	Fatty acid dental cement	Class IIa
Dental material mixing nozzle	Dental material mixing nozzle	Class I
Dental material injection cannula single-use	Dental material injection cannula single-use	Class I
Dental material cartridge-plunging applicator two-component manual	Dental material cartridge-plunging applicator two-component manual	Class I