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K Number
K162021
Device Name
3.0 Dynamic TiBase
Manufacturer
TALLADIUM ESPANA, SL
Date Cleared
2018-05-04

(652 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

3.0 Dynamic TiBase are intended for use with dental implants as a support for multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) Pre-market Notification does not contain information about acceptance criteria or the study that proves a device meets those criteria, specifically concerning an AI/ML medical device.

The document is a clearance letter for a dental device called "3.0 Dynamic TiBase," which is a physical endosseous dental implant abutment. The content discusses:

  • The FDA's review and determination of substantial equivalence to legally marketed predicate devices.
  • Regulatory classifications, general controls, and additional controls (if applicable).
  • Requirements for registration, listing, labeling, medical device reporting, and good manufacturing practices.
  • Contact information for the FDA's Division of Industry and Consumer Education.
  • The "Indications for Use" for the 3.0 Dynamic TiBase, including compatibility with specific implant systems (DIO® and OSSTEM®), dimensions, retention type, screw type, angulation, and abutment connection.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving device performance, especially for an AI/ML device, as this document is not related to such a product or study.

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)