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K Number
K210903
Device Name
IS Multi Unit Abutment System
Manufacturer
Neobiotech Co., Ltd.
Date Cleared
2021-07-23

(119 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
DE
Reference & Predicate Devices
K120530,K180282,K181138,K182091,K182194,K161689
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

Device Description

IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.

IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.

All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets them in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a dental implant abutment system (IS Multi Unit Abutment System) and focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for traditional medical devices, not typically AI/ML-driven ones.

Therefore, I cannot provide the requested information, including:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

The document primarily details device descriptions, indications for use, material specifications, and comparisons to predicate devices in terms of physical characteristics and intended use. It also mentions non-clinical testing data related to sterilization and fatigue testing for the physical dental device components.

§ 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.)