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FDA 510(k)

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

Numéro K : K242366 · 2025-01-10

DemandeurOverfibers S.R.L.
Date de décision2025-01-10
Code produitEMA
Comité consultatifDE
DécisionSubstantially Equivalent

Résumé du dispositif

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Overfibers S.R.L.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K242366. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Overfibers S.R.L.. The 510(k) number is K242366.

When did OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment receive FDA 510(k) clearance?

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment received FDA 510(k) clearance on 2025-01-10, under 510(k) number K242366.

Who is the listed applicant for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA 510(k) record lists Overfibers S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment?

The FDA product code for OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment is EMA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : EMA)

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Source officielle

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