← Back to catalogue

Spi Variomulti Abutment

FDA 510(k)

Class II (US FDA 510(k))

510(k) K072856

by Thommen Medical AG

Identifiers

510(k) Number
K072856 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 SPI VARIOMULTI ABUTMENT is a dental abutment designed for use with dental implant systems. It is intended to connect a dental prosthesis to an endosseous implant in the maxillary and/or mandibular arch.

This device is supplied as a reusable component for use in dental prosthetic workflows, supporting both digital and conventional approaches. It has received FDA 510(k) clearance (K072856) and is substantially equivalent to predicate devices, with no claims regarding sterility, single-use status, MRI safety, or specific storage conditions provided in the data.

Frequently asked questions

What is the SPI VARIOMULTI ABUTMENT used for?

The SPI VARIOMULTI ABUTMENT is intended to connect a dental prosthesis to an endosseous implant in the maxillary and/or mandibular arch, serving as a component in dental prosthetic workflows for both digital and conventional approaches.

Is the SPI VARIOMULTI ABUTMENT supplied sterile or for single-use?

The device is supplied as a reusable component, and the provided data includes no claims regarding sterility or single-use status, meaning it is intended for multiple uses after appropriate cleaning and reprocessing by the user.

What regulatory clearance does the SPI VARIOMULTI ABUTMENT have?

The SPI VARIOMULTI ABUTMENT has received FDA 510(k) clearance under submission number K072856, and was determined to be substantially equivalent to predicate devices, as indicated by the decision code SESE and clearance type Traditional.

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: PDF VARIOmulti, PDF 510(k) Summary Thommen Medical AG SPI® VARIOmulti Abutmen, PDF VARIOmulti - Thommen Medical, SPI VARIOMULTI ABUTMENT (K072856) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Thommen Medical AG

Sources (1)

  • FDA 510(k) K072856 24 fields · synced Oct 6, 2026