|
MSA code |
16959
|
Basic UDI-DI |
|
Seadme klass |
Meditsiiniseade
|
Medical Device Nomenclature |
|
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
|
Authorised representative |
Kerr Italia S.r.l
|
In register from |
10/12/2021
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
|
|
|
|