FDA 510(k)

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment

Numéro K : K240531 · 2024-07-30

DemandeurBioHorizons Implant Systems, Inc.

Date de décision2024-07-30

Code produitNHA

Comité consultatifDE

DécisionSubstantially Equivalent

Résumé du dispositif

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K240531. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K240531.

When did SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment receive FDA 510(k) clearance?

SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment received FDA 510(k) clearance on 2024-07-30, under 510(k) number K240531.

Who is the listed applicant for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment?

The FDA product code for SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment is NHA.

Essais cliniques associés

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Autres dossiers indiquant BioHorizons Implant Systems, Inc. en tant que demandeur

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Dispositifs connexes (Code : NHA)

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Source officielle

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