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NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Temporary prosthetic components have a maximum duration of usage of 180 days.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses.

NUVENTUS NV.C™ FINAL PROSTHETIC
NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.

The NUVENTUS NV.C™ Prosthetic Components product portfolio consists of NUVENTUS NV.C™ Healing Components, NUVENTUS NV.C™ Temporary Prosthetic Components, NUVENTUS NV.C™ Multi-unit Abutments, and NUVENTUS NV.C™ Final Prosthetic. NUVENTUS NV.C™ Prosthetic Components product portfolio are intended to be used with the NUVENTUS NV.C™ Dental Implant System (K233081).

NUVENTUS NV.C™ HEALING COMPONENTS
NUVENTUS NV.C™ Healing Components may come in different designs, either with cap or screw portion machined as one piece or with an integrated occlusal screw. Different shapes, transmucosal heights are available. Healing components are components that cover the implant or abutment platform and prevent tissue overgrowth during the healing phase of the implant. The threaded portion of the healing components fits inside the internal threads of the implant or abutment, while the head of the healing components covers the top surface of the implant (the implant head) or abutment.

NUVENTUS NV.C™ TEMPORARY PROSTHETIC COMPONENTS
The NUVENTUS NV.C™ Temporary Prosthetic Components line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

NUVENTUS NV.C™ MULTI-UNIT ABUTMENTS
NUVENTUS NV.C™ Multi-unit Abutments are premanufactured dental abutments used for restoration of NUVENTUS NV.C™ Dental Implant of different diameters and lengths. The Multi-unit Abutments are available in NP and RP platform sizes; 0°, 17° and 30° angulations; various transmucosal heights and hexagonal index orientations. Multi-unit Abutments are co-packed with abutment carrier and screw. The abutments are delivered sterile for immediate use.

NUVENTUS NV.C™ FINAL PROSTHETIC
The NUVENTUS NV.C™ Final Prosthetic line consists of abutments and copings which are used for the restoration of NUVENTUS NV.C™ Dental Implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The provided FDA 510(k) Clearance Letter for NUVENTUS NV.C™ Prosthetic Components does NOT describe a device that uses AI or machine learning. It describes conventional prosthetic components for dental implants.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data, including:

• MRI Safety: Evaluation of components in an MR environment based on scientific rationale and published literature, addressing magnetically induced displacement force and torque per FDA guidance.
• Sterilization Validation:
  • Gamma irradiation validation (25 kGy dose) for sterile components according to ISO 11137-1 and ISO 11137-2.
  • Bacterial endotoxin testing (LAL test) according to ANSI/AAMI ST72 (

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The TiGEN Abutment, PMMA Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

The PMMA Abutment is indicated to be used pror to the final components to maintain, stabilize and shape the soft tissue during the healing plase. They must be placed out of occlusion and are for temporary use (3 months).

For TiGEN Abutment and PMMA Abutment, all digitally designed abutments for use with PMMA Abutment and TiGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.

The PMMA Abutment is a temporary prosthesis used until the final prosthesis is placed for up to three months. The PMMA Post is machined with the temporary prosthetic in accordance with the intraoral structure by using dental CAD/CAM technology. The PMMA Cuff is made of Ti-6Al-4V ELI alloy and available in various gingival heights. The PMMA Post is made of Polymethyl methacrylate and available in various diameters and lengths so that it can be used according to individual patient conditions. All PMMA Abutment is provided non-sterile with abutment screw. The milled PMMA Abutment must be sterilized by users prior to use.

The Scan Healing Abutment designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.

This document pertains to a 510(k) premarket notification for dental implant abutments and does not contain information about an AI/ML medical device. Therefore, a table of acceptance criteria and a study proving the device meets the criteria, as requested by the prompt, cannot be extracted from the provided text for an AI/ML context.

The document discusses the substantial equivalence of the "TiGEN Abutment, PMMA Abutment and Scan Healing Abutment" to already marketed predicate devices. The studies mentioned are primarily bench tests, biocompatibility evaluations, and sterilization/shelf-life validations, which are standard for physical medical devices. There is no mention of an AI/ML component, AI/ML device performance metrics, or related study methodologies like multi-reader multi-case (MRMC) studies.

Without information on an AI/ML component, the requested details such as sample size for test sets (for AI), data provenance, expert ground truth establishment, MRMC studies, standalone AI performance, and training set details are not applicable and cannot be provided.

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