FDA 510(k)

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems

K-Nummer: K252582 · 2025-11-18

AntragstellerPrismatik Dentalcraft, Inc.

Entscheidungsdatum2025-11-18

ProduktcodeNHA

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252582. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K252582.

When did Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems receive FDA 510(k) clearance?

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252582.

Who is the listed applicant for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

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

What is the FDA product code for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems?

The FDA product code for Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems is NHA.

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Weitere Einträge mit Prismatik Dentalcraft, Inc. als Antragsteller

K261802Glidewell™ Denture Base Resin K262239Obsidian® Press Over Zirconia K254283BruxZir® Shaded 16 PLUS K252446BruxZir® NOW K250302Flexible Partial Resin K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

Alle 37 Geräte anzeigen →

Verwandte Geräte (Code: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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