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Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureS…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191475

by Nobel Biocare AB

Identifiers

510(k) Number
K191475 FDA 510(k)
FDA Product Code
KCT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nobel Biocare N1 PureSet Tray and Plate are dental surgical trays and plates designed for the handling and assembly of dental implants and prosthetic components. These devices facilitate the precise placement and fixation of implant abutments and prosthetic restorations in oral and maxillofacial surgery.

Supplied sterile and intended for single-use, these trays and plates are used in hospital-based dental clinics. They comply with FDA 510(k) clearance under the General Hospital advisory committee and are authorised under the Medical Device Regulation (MDR). The trays and plates are available in specific configurations to accommodate various implant and prosthetic systems.

Frequently asked questions

Are the Nobel Biocare N1 PureSet Tray and Plate designed for reuse in multiple procedures, or are they intended for single-use only?

The Nobel Biocare N1 PureSet Tray and Plate are explicitly supplied sterile and intended for single-use only. This design ensures infection control and maintains sterility during dental implant and prosthetic procedures, as outlined in the manufacturer’s specifications.

What types of clinical settings are these trays and plates intended for, and how do they support dental implant procedures?

These trays and plates are designed for use in hospital-based dental clinics, where precise handling and assembly of dental implants and prosthetic components are required. They facilitate the accurate placement and fixation of implant abutments and prosthetic restorations, streamlining workflows in oral and maxillofacial surgery.

How many configurations or sizes are available for the PureSet Tray and Plate, and do they accommodate different implant systems?

The PureSet Tray and Plate come in specific configurations tailored to various dental implant and prosthetic systems. While exact sizes or models aren’t detailed here, the product is engineered to ensure compatibility with multiple implant and prosthetic setups, allowing clinicians to select the appropriate tray or plate for their procedure.

What regulatory pathways have these devices undergone, and how does that affect their use in clinical practice?

The Nobel Biocare N1 PureSet Tray and Plate have undergone FDA 510(k) clearance under the General Hospital advisory committee (K191475) and are authorized under the Medical Device Regulation (MDR). This means they meet U.S. and EU regulatory standards for safety and performance, ensuring they can be legally used in approved clinical settings for their intended purpose.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (2)

  • FDA 510(k) K191475 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026