(263 days)
K/DEN 012307
No
The summary describes a dental composite material and its physical properties, with no mention of AI or ML.
No
The device is a dental restorative material used for core build-ups and as a base cement for pins and posts, not for treating diseases or conditions.
No
Explanation: The devices are described as materials for fabricating core build-ups and as a base cement, indicating they are restorative dental materials, not diagnostic.
No
The device description clearly states it is a "dual-cure (auto and photo), nanofilled resin composite material" presented in a syringe and cartridge, indicating it is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of core build-ups and as a base cement to affix pins and posts in dentistry. This is a direct application within the body (or on a part of the body) for structural purposes.
- Device Description: The device is a dental material (resin composite) used for filling and luting.
- Lack of IVD Characteristics: The description does not mention any use for testing samples in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. There is no mention of analyzing biological specimens like blood, urine, or tissue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a restorative and structural material used directly in dental procedures.
N/A
Intended Use / Indications for Use
The subject devices are intended to serve for the fabrication of core build-ups. They are also intended to serve as a base cement to affix pins and posts. They may be used with any Bis-GMA compatible bonding agent.
Product codes
EBF
Device Description
The subject devices are dual-cure (auto and photo), nanofilled resin composite materials. They are stackable for easy setting, with no condensation, radio opaque and fluoride releasing.
The subject devices are presented in an Automix syringe and a Cartridge used with a gun. Dentocore and Dentocore Body have the same intended use; the former possessing a relatively higher viscosity. This quality is a selection for practitioners choosing this type of material.
The subject devices present numerous advantages, notably the following:
- . Good compressive strength
- Low polymerization shrinkage .
- Fluorure release .
- . Very high radio opacity properties
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications". In support of this, Itena Clinical has provided information to demonstrate conformity with FDA's guidance document entitled Dental Composites -Premarket Notification, November 1998 and ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials.
In vitro Cytotoxicity assay have been performed in accordance to ISO 7405:1997 and ISO 10993, using the well-characterized mouse cell line L929 cultured in tissue culture dishes. The Positive and Negative Controls resulted in cell reactions that have been interpreted as Moderate-severe and none, respectively, validating the test. The subject devices were found as non-cytotoxic.
Key Metrics
Not Found
Predicate Device(s)
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Abbreviated 510(k) Summary
MAR 0 5 2013
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- Name/Address of Submitter:
Itena Clinical 83 avenue Foch 75116 Paris FRANCE
- Name/Address of Submitter:
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Contact Person: Louis-Paul Marin Co-President, BCF Certification inc. Phone: (514) 397-5546 (514) 397-8515 Fax: Email: Ipmarin@bcf.ca
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Date Summary Prepared: August 25, 2012
- Devices Names: Dentocore Body, Dentocore 4.
- પં Device Classification: II
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- Classification Product Code: EBF
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- Common Name: Dual-cured core built-up material
- Regulatory number: 872.3690 8.
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- Predicate Device:
| A . I . SE ANNUAL CANADA AND AND AND AND AND | ---------------------------------- |
|---|---|
| JIXacore/ | |
| Dual | |
| בחחק בצוג |