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Terviseamet

Medical device

MSA code 16801
UDI code
Seadme klass Meditsiiniseade
Risk class IIa
Appliance -
Device name (in Estonian) Straumann® Service Set
Device name (in English) Straumann® Service Set
Intended use (is Estonian) Hoolduskomplekt Service Set on ette nähtud Straumann®-i implantaat-toendi süsteemi päästmiseks, kui proteesikomponent on kahjustunud või kinnikii- lunud, ilma et peaks eemaldama osseointegreerunud implantaadi. Hoolduskomplekt Service Set on ette nähtud ossointegreerunud implantaa- diga patsientidelt kahjustunud või kinnikiilunud proteesikomponendi eemal- damiseks. Hoolduskomplekti Service Set võivad kasutada ainult hambaarstid.
Intended use (in English) The Service Set is intended to rescue a Straumann® implant-abutment sys- tem, where the prosthetic component is damaged or stuck, without removing an osseointegrated implant. The Service Set is indicated for the removal of a damaged or stuck prosthetic component in patients with an osseointegrated implant. The Service Set is to be used by a dentist only.
Type/model/article number 026.0076; 026.0077; 026.0078; 026.0079; 026.0080; 026.0082; 066.0079
Notified body 0123
Manufacturer Institut Straumann AG
Authorized spokesman Etkon GmbH
In register from 07/29/2021
Status Active
EHK soodustus EHK soodustus puudub
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