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 - FKG Dentaire SA

Address:

Crêt-du-Locle 4

La Chaux-de-Fonds

2304

Switzerland

Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge

CB24 9BZ

England United Kingdom

Code/Term Type

Endodontic enlarger reusable Endodontic enlarger reusable Class I

Manual endodontic file/rasp reusable Manual endodontic file/rasp reusable Class IIa

Manual endodontic filling material spreader Manual endodontic filling material spreader Class IIa

Rotary/reciprocating endodontic file/rasp reusable Rotary/reciprocating endodontic file/rasp reusable Class I

Endodontic obturation material distribution endpiece reusable Endodontic obturation material distribution endpiece reusable Class IIa

Endodontic plugger Endodontic plugger Class IIa

Endodontic broach serrated single-use Endodontic broach serrated single-use Class I

Rotary/reciprocating endodontic file/rasp single-use Rotary/reciprocating endodontic file/rasp single-use Class IIa

Rotary/reciprocating endodontic file/rasp single-use Rotary/reciprocating endodontic file/rasp single-use Class IIa

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
Endodontic enlarger reusable	Endodontic enlarger reusable	Class I
Manual endodontic file/rasp reusable	Manual endodontic file/rasp reusable	Class IIa
Manual endodontic filling material spreader	Manual endodontic filling material spreader	Class IIa
Rotary/reciprocating endodontic file/rasp reusable	Rotary/reciprocating endodontic file/rasp reusable	Class I
Endodontic obturation material distribution endpiece reusable	Endodontic obturation material distribution endpiece reusable	Class IIa
Endodontic plugger	Endodontic plugger	Class IIa
Endodontic broach serrated single-use	Endodontic broach serrated single-use	Class I
Rotary/reciprocating endodontic file/rasp single-use	Rotary/reciprocating endodontic file/rasp single-use	Class IIa
Rotary/reciprocating endodontic file/rasp single-use	Rotary/reciprocating endodontic file/rasp single-use	Class IIa