
Dental Anti-Snore Device
Kev kho hniav los tiv thaiv-snre ntaus ntawv yog ib qho kev cai- haum cov khoom siv hauv qhov ncauj uas hnav thaum pw tsaug zog uas maj mam muab lub puab tsaig qis rau pem hauv ntej kom cov pa qhib. Raws li qhov ua tau zoo, tsis yog -invasive lwm txoj rau cov tshuab CPAP loj, nws txo qis snoring thiab alleviates me ntsis - rau -mob obstructive pw tsaug zog apnea, muab cov neeg mob txoj kev xis nyob rau ntsiag to, ntau restorative pw tsaug zog.
Hauj lwm lawm
Khoom Description
A kho hniav tiv thaiv-snore ntaus ntawvyog ib qho kev cai - haum lub qhov ncauj khoom siv thaum pw tsaug zog uas maj mam muab lub puab tsaig qis rau pem hauv ntej kom qhib txoj hlab pa. Raws li qhov ua tau zoo, tsis yog -invasive lwm txoj rau loj CPAP cov cav tov, nws txo snoring thiab alleviates me ntsis - rau -mob obstructive pw tsaug zog apnea, muab cov neeg mob ib tug xis txoj kev mus rau ntsiag to, ntau restorative pw tsaug zog.
Ntsiab nta
Kev cai - haum kev nplij siab- digitally tsim los ntawm koj tus neeg mob qhov kev xav ntawm kev kho hniav lossis kev soj ntsuam hauv lub cev kom zoo, ruaj khov.
Yooj yim hnav- compact, lightweight design with smooth, polished surfaces for all - hmo ntuj kev nplij siab.
Adjustable nce qib- lub puab tsaig nce ntxiv- kev hloov kho txoj hauj lwm cia cov kws kho mob zoo- kho kom haum rau cov txiaj ntsig zoo.
Durable & biocompatible- kev kho mob- qib, FDA- cov ntaub ntawv ua raws li tiv thaiv hnav thiab muaj kev nyab xeeb rau lub sijhawm ntev - siv hmo ntuj.
Portable & huv si- qhov loj me thiab kev tu yooj yim ua rau nws zoo tagnrho rau kev siv hauv tsev thiab mus ncig.
Cov lus qhia
Primary snoring thiab me -rau-moderate obstructive pw tsaug zog apnea (OSA)
Cov neeg mob uas tsis tuaj yeem zam lossis tsis kam kho CPAP
Cov neeg mob nrhiav kev txav mus los, tsis yog -txoj kev kho pw tsaug zog
Cov neeg laus nrog kev noj qab haus huv ntawm cov hniav thiab kev txhawb nqa periodontal txaus
Khoom Specifications
Khoom siv: biocompatible thermoplastic resin / thermoformed kho mob- qib polymer
Hom: mandibular advancement device (MAD); ib leeg - puab tsaig lossis dual - lub puab tsaig tsim muaj
Kev xaiv: kev cai los yog boil-thiab- tom; adjustable los yog ruaj nce qib; ntau qhov ntau thiab tsawg
Lub sijhawm ua haujlwm: niaj hnub 2-3 hnub, complex 3-5 hnub
Vim li cas thiaj xaiv tuomei Dental Lab
Raws li tus kws kho hniav OEM/ODM chaw tsim tshuaj paus nrog 10+ xyoo ntawm kev paub thiab 120+ kws kho hniav, peb xa cov meej, zoo ib yam los tiv thaiv- cov cuab yeej snore backed los ntawm tag nrho cov ntaub ntawv pov thawj (MDR CE, FDA). Peb cov streamlined digital workflow thiab Hong Kong DHL / UPS》shipping (2-3 hnub ua hauj lwm) xyuas kom meej koj cov ntaub ntawv tuaj txog raws sij hawm, txhua txhua lub sij hawm.
FDA Q&A
Q1: Puas yog qhov tshuaj tiv thaiv kab mob no yog FDA-snore device?
Yog lawm. Peb cov khoom siv tiv thaiv-snre qhov ncauj yog tsim los ua raws li FDA cov cai rau cov khoom siv kho mob Class II, nrog rau cov npe khoom tsim nyog thiab cov ntaub ntawv tswj hwm hauv qhov chaw.
Q2: FDA kev faib tawm yog dab tsi rau kev tiv thaiv -snore li?
Anti- cov cuab yeej siv qhov ncauj qhov ncauj yog feem ntau cais raws liCov khoom siv kho mob Class IIraws li FDA txoj cai. Nyob ntawm tus qauv tsim, lawv yuav xav tau510 (k) tshem tawmlos yog tsim nyog rau 510 (k) kev zam raws li cov khoom lag luam cuam tshuam.
Q3: Puas yog cov khoom siv biocompatible thiab nyab xeeb?
Yog lawm. Txhua cov ntaub ntawv raug kuaj xyuas biocompatibility raws liTS EN ISO 10993(cytotoxicity, rhiab heev, thiab khaus khaus), lees paub kev nyab xeeb rau ntev - siv intraoral ntev.
Q4: Peb lub chaw kuaj mob lossis chaw kuaj mob puas tuaj yeem faib cov cuab yeej no hauv Asmeskas kev lag luam?
Yog lawm, muab koj lub chaw tuav pov hwm tsim nyog FDA tso npe thiab ua raws li daim ntawv lo thiab tshaj tawm cov cai. Peb muab tag nrho cov ntaub ntawv pov thawj los txhawb koj txoj kev ua raws li FDA thiab kev lag luam nkag.
Q5: Koj puas muab FDA-cov ntaub ntawv hais txog kev ua haujlwm?
kiag li. Peb muab cov ntaub ntawv ua tiav cov ntaub ntawv, cov ntaub ntawv pov thawj, thiab cov ntaub ntawv ua raws cai los pab txhawb koj cov kev tswj hwm thiab cov lus nug ntawm cov neeg siv khoom.
Cim npe nrov: Tuam Tshoj Dental Anti-Snore ntaus ntawv, Tuam Tshoj Dental Anti-snore ntaus ntawv manufacturers, lwm tus neeg, Hoobkas







