(263 days)
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.
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.
This 510(k) summary describes an Abbreviated 510(k) submission for a dental material, not an AI/ML medical device. Therefore, much of the requested information about device performance, study design, and ground truth establishment, which are specific to AI/ML device evaluations, is not applicable or available in this document.
However, I can extract the relevant information provided for this device based on the submission type and available details:
1. Table of Acceptance Criteria and Reported Device Performance
As this is an Abbreviated 510(k) for a dental material, the "acceptance criteria" are related to conformity with recognized standards and demonstrating non-inferiority to a predicate device. Performance is primarily reported in relation to these standards and general material properties.
| Acceptance Criteria / Standard | Reported Device Performance (Dentocore Body, Dentocore) |
|---|---|
| Cytotoxicity (ISO 7405:1997 and ISO 10993) | Non-cytotoxic |
| Material Properties (General) | Good compressive strength, Low polymerization shrinkage, Fluoride release, Very high radio opacity properties |
| Premarket Notification Guidance Conformity | Conforms to FDA's guidance document "Dental Composites - Premarket Notification, November 1998" |
| International Standard Conformity | Conforms to ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials |
| Equivalence to Predicate Device (JIXacore/Dual) | Substantially equivalent for indicated uses and technological characteristics. |
Study Information (as applicable to a dental material 510(k)):
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions "in vitro Cytotoxicity assay" and general material characteristic testing. Specific sample sizes for these tests are not provided in this summary.
- Data Provenance: The studies were in-vitro (laboratory-based) as per the cytotoxicity assay and material property evaluations. The country of origin for the data is not specified, though the submitter is Itena Clinical from Paris, France. The studies are by definition prospective in the context of generating data for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. For dental material testing (e.g., cytotoxicity, mechanical properties), "experts" are typically involved in designing and interpreting the scientific experiments, following established protocols. The concept of "ground truth" established by a panel of human experts is not relevant here as the performance metrics are objective physical or biological measurements.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are for human rater discrepancies in diagnostic image interpretation or similar tasks. This is not relevant for in-vitro material testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a dental material, not an AI-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a dental material, not an algorithm or software device.
7. The type of ground truth used
- For the cytotoxicity assay, the "ground truth" was established by standardized biological assay protocols (ISO 7405:1997 and ISO 10993) using a well-characterized mouse cell line (L929). The reaction of positive and negative controls validated the test.
- For other material properties (compressive strength, polymerization shrinkage, fluoride release, radio opacity), the "ground truth" is based on objective scientific measurements and adherence to recognized material testing standards (like ISO 4049).
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of evaluating a dental material as it's not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
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Abbreviated 510(k) Summary
MAR 0 5 2013
-
- Name/Address of Submitter:
Itena Clinical 83 avenue Foch 75116 Paris FRANCE
- Name/Address of Submitter:
-
Contact Person: Louis-Paul Marin Co-President, BCF Certification inc. Phone: (514) 397-5546 (514) 397-8515 Fax: Email: Ipmarin@bcf.ca
-
Date Summary Prepared: August 25, 2012
- Devices Names: Dentocore Body, Dentocore 4.
- પં Device Classification: II
-
- Classification Product Code: EBF
-
- Common Name: Dual-cured core built-up material
- Regulatory number: 872.3690 8.
-
- Predicate Device:
| A . I . SE ANNUAL CANADA AND AND AND AND AND | ---------------------------------- |
|---|---|
| JIXacore/Dualבחחק בצוג | <012307 |
| SELL 11 1 |
-
- Devices 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.
- Devices 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 present numerous advantages, notably the following:
- . Good compressive strength
- Low polymerization shrinkage .
- Fluorure release .
- . Very high radio opacity properties
-
- Indication 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.
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-
- Brief Description of Clinical and Non-clinical Testing: 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.
- Brief Description of Clinical and Non-clinical Testing: 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.
-
- Conclusion Drawn: Based on their indications for use, technological characteristics and comparison to predicate devices, the subject devices have been shown to be safe and effective for their intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Itena Clinical C/O Ms. Louis-Paul Marin Co-President BCF Certification, Incorporated 500 Boul Cartier West Laval, Canada H7V 5B7
Re: K121769
Trade/Device Name: Dentocore, Dentocore Body Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 16, 2013 Received: February 11, 2013
Dear Mr. Marin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication 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.
Concurrence of CDRH Office of Device Evaluation
Prescription Use _X (per 21CFR 801.109) OR Over-the-counter Use
Mary S. Runner -S
Swoon Runner, DDS, PA 2013.03.05 11:15:37
-05'00"
(Division Sign-Off) Division of Anesthesiology, General Hosp ... Infection Control, Dental Device
510(k) Number: KY21769
2052177.1
1-1
§ 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.