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 - Dentsply Sirona Orthodontics Inc. (Florida)

Address:

7290 26th Court East

Sarasota

Florida 34243

United States

Authorised Representative/ UK Responsible Person
Name: Dentsply IH Limited
Address:

Building 3 The Heights Brooklands

Weybridge

Surrey KT13 0NY

England United Kingdom

Code/Term Type

Carbide dental bur reusable Carbide dental bur reusable Class IIa

Diamond dental bur reusable Diamond dental bur reusable Class IIa

Interproximal reduction kit Interproximal reduction kit Class IIa

Orthodontic appliance cleanser Orthodontic appliance cleanser Class IIb

Dental appliance fabrication material thermoplastic Dental appliance fabrication material thermoplastic Class IIa

Orthodontic retainer support kit Orthodontic retainer support kit Class IIb

Bite relief pad Bite relief pad

Dental abrasive strip reusable Dental abrasive strip reusable Class I

Orthodontic aligner/retainer seater single-use Orthodontic aligner/retainer seater single-use Class I

Orthodontic appliance remover Orthodontic appliance remover Class I

Orthodontic appliance remover Orthodontic appliance remover 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
Carbide dental bur reusable	Carbide dental bur reusable	Class IIa
Diamond dental bur reusable	Diamond dental bur reusable	Class IIa
Interproximal reduction kit	Interproximal reduction kit	Class IIa
Orthodontic appliance cleanser	Orthodontic appliance cleanser	Class IIb
Dental appliance fabrication material thermoplastic	Dental appliance fabrication material thermoplastic	Class IIa
Orthodontic retainer support kit	Orthodontic retainer support kit	Class IIb
Bite relief pad	Bite relief pad
Dental abrasive strip reusable	Dental abrasive strip reusable	Class I
Orthodontic aligner/retainer seater single-use	Orthodontic aligner/retainer seater single-use	Class I
Orthodontic appliance remover	Orthodontic appliance remover	Class I
Orthodontic appliance remover	Orthodontic appliance remover	Class I