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Terviseamet

Medical device

MSA code 16959
UDI code
Seadme klass Meditsiiniseade
Risk class IIa
Appliance -
Device name (in Estonian) Damon Ultima Archwires
Device name (in English) Damon Ultima Archwires
Intended use (is Estonian) Damoni süsteem on tõendatud süsteem passiivsest roostevabast terasest iseligeeruvatest breketitest, kõrgtehnoloogilistest kaartest ja minimaalselt invasiivsest raviprotokollist, mis on loodud õrna ja kerge jõu süsteemina. Kõik need süsteemid hõlmavad ülalõua- ja alalõualuu breketeid (5-5). Kõik breketid on toodetud liugmehhanismiga, mis avaneb ortodontilise tööriista ja ravimehaanikaga, mis kasutab Damoni protokolli
Intended use (in English) The Damon System is a proven combination of passive stainless steel self-ligating brackets, high-tech archwires and minimally invasive treatment protocol designed as a gentle, light force system. Each of these systems encompass maxillary and mandibular brackets from bicuspid to bicuspid (5-5). All brackets are designed with a slide that opens with an orthodontic tool and treatment mechanics that utilize the Damon prescription
Type/model/article number 227-1118
227-1161
227-1163
227-1267
227-1272
Additional information There is no IFU available for this product. in accordance with the MDD, (annex I, article 13) class I and certain class IIa products are not obliged to be provided with an IFU. Our DoC are in alignment with the mdd. The information as required in the mdd, annex 1, sectie 13 is listed on our DoC
Notified body 2797
Manufacturer Ormco Corporation
Authorized spokesman Kerr Italia S.r.l
In register from 10/12/2021
Status Active
EHK soodustus EHK soodustus puudub
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