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Novaloc TiN Abutments

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K193046

by Institut Straumann AG

Identifiers

510(k) Number
K193046 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Novaloc TiN Abutments are dental abutments designed for use with Straumann dental implants. These components facilitate the connection between the implant fixture and the prosthetic crown or restoration, ensuring stability and retention in implant-supported restorations.

Supplied as part of the Straumann Retentive System, these abutments are intended for single-use and are regulated under FDA 510(k) clearance (K193046) and the EU Medical Device Regulation (MDR). They are engineered for dental office use and must be handled in accordance with aseptic protocols. No specific MRI safety classification is stated in the provided data.

Frequently asked questions

Are the Straumann® Retentive System – Novaloc TiN Abutments reusable, or are they meant for single-use only? Why does this matter in a clinical setting?

The Straumann® Retentive System – Novaloc TiN Abutments are explicitly designed for single-use only. This matters clinically because single-use components reduce the risk of cross-contamination between patients, which is critical in dental offices where aseptic protocols must be strictly followed. Reusing these abutments could compromise patient safety by introducing bacterial or particulate contamination, potentially leading to peri-implant infections or complications.

What specific types of dental restorations are these abutments intended to support, and how do they ensure stability?

These abutments are designed to connect Straumann dental implants to prosthetic crowns or restorations, ensuring stability and retention in implant-supported restorations. Their engineering focuses on creating a secure interface between the implant fixture and the final restoration, which is essential for long-term functionality and patient comfort. They are not intended for any other type of dental restoration.

How should these abutments be stored, and what precautions should be taken to maintain their integrity?

While the provided data does not specify exact storage conditions, as dental implants and abutments, these components should be stored in a clean, dry environment to prevent moisture damage or contamination. They must be handled under aseptic conditions to ensure sterility before use, as they are intended for direct placement in the oral cavity. Avoid exposure to extreme temperatures or direct sunlight, which could compromise their structural integrity.

Are there different sizes or models available for the Novaloc TiN Abutments, and if so, how does a clinician determine the correct fit for a patient?

The data does not explicitly list individual sizes or models, but as part of the Straumann Retentive System, these abutments are likely designed to match specific implant diameters or platforms (e.g., Straumann’s standard implant sizes). Clinicians would determine the correct fit by referencing Straumann’s patient-specific or implant-specific guidelines, which typically involve measuring the implant’s platform diameter and selecting the corresponding abutment. Always follow the manufacturer’s instructions for proper sizing and placement.

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. Sources consulted: Herzlich willkommen bei Straumann, Welcome to Straumann, Dashboard | Straumann, Straumann® eShop – Klicken. Finden. Lächeln.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Institut Straumann AG

Sources (2)

  • FDA 510(k) K193046 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026