(141 days)
Not Found
No
The 510(k) summary describes a dental cement and its physical properties and performance metrics, with no mention of AI or ML.
Yes
The device is a permanent dental cement used for the cementation of posts, crowns, bridges, veneers, inlays, and onlays, which are restorative procedures aimed at treating dental issues and improving oral health and function.
No
The device is a resin cement intended for permanent cementation in dentistry, not for diagnosing medical conditions.
No
The device description clearly states it is a "permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement," which is a physical material, not software. The performance studies also focus on material properties like strength, solubility, and setting time.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the permanent cementation of dental restorations (posts, crowns, bridges, etc.). This is a direct application within the body for structural support and restoration, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description identifies it as a "permanent, radio-opaque dual cured ... resin cement." This aligns with a material used for bonding within the oral cavity.
- Lack of IVD Characteristics: The description and performance studies focus on physical and mechanical properties relevant to dental cementation (bond strength, flexural strength, solubility, working/setting time, film thickness, shelf life). There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Relevant Standards: The cited standards (ISO 4049, ISO 7405, ISO 9917-1, ISO 10993-5) are related to dental materials and biocompatibility, not IVD testing.
In summary, the device is a dental cement used for bonding restorations, which falls under the category of a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays.
Product codes
EMA
Device Description
TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement.
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 establish substantial equivalent to the predicates and demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification. August 1998 and the following recognized consensus standards: - ISO 4049 - Dentistry - Dentistry -- Polymer-based restorative materials; - ISO 7405 Dentistry dentistry evaluation of biocompatibility of medical ● devices used in dentistry; - ISO 9917-1 Dentistry-- water-based cements part 1: powder/liquid acid-base ● cements; and - . ISO 10993-5 - Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity. TotalC-Ram meets or surpasses requirements set forth therein, notably as regards flexural strength, solubility, film thickness and radiopacity. Clinical performance testing has not been performed for the subject device.
Key Metrics
- Shear Bond Strength to Zirconia (MPa): 11.2
- Flexural strength (MPa): 125.5
- Solubility (µg/mm3): LOW
- Working time at 22°C (min): 4.5
- Setting time at 37 °C (min): 2.5
- Film thickness (µg/mm3): 10
- Shelf life (Years): 2
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2017
Itena Clinical % Louis-Paul Marin President Lok North America Inc. 2025 Rue Michelin Laval, H7L 5B7 CANADA
Re: K162960
Trade/Device Name: TotalC-RAM Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 19, 2016 Received: December 27, 2016
Dear Louis-Paul 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, listing 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | |
|---|---|
| Device Name | TOTALC-RAM |
| Indications for Use (Describe) | It is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
3
Abbreviated 510(k) Summary
| 1. | Name/Address of Submitter: | Itena Clinical |
|---|---|---|
| 2. | Contact Person: | Louis-Paul Marin |
| LOK North America Inc. | ||
| Phone: (514) 928-5546 | ||
| Email: marin.lp@lok-corporation.com |
- October 12th, 2016 3. Date Summary Prepared:
- Devices Names: TotalC-Ram 4.
-
- Device Classification: II, 21 CFR 872.3275
-
- Common name: Dental Cement
-
- Classification Product Code: EMA
- Predicate Devices: 8.
| TotalCem | K121804 |
|---|---|
| DentoCem | K121804 |
9. Devices Description:
TotalC-Ram is permanent, radio-opaque dual cured (auto/photopolymerizable) self-etch and self-adhesive resin cement. The following table shows the significant technological characteristics for the subject device and indicates the following similarities and differences with the predicate devices:
| Chemical
Composition: | Subject Device | Predicates
TotalCem | Predicates
DentoCem |
|--------------------------|----------------|------------------------|------------------------|
| Matrix: | UDMA | UDMA | UDMA |
| | Bis-GMA | Bis-GMA | Bis-GMA |
| | TEGDMA | TEGDMA | TEGDMA |
| Fillers | Barium Glass | Barium Glass | Barium Glass |
| | Fumed Silica | Fumed Silica | Fumed Silica |
4
| Physical/Mechanical | Subject Device | Predicates | Predicates |
|---|---|---|---|
| Properties: | TotalCem | DentoCem | |
| Delivery | Automix | Automix | Automix |
| Curing Method | Light | ||
| Self-Cure | Light | ||
| Self-Cure | Light | ||
| Self-Cure | |||
| Radiopacity (% Al) | Yes | Yes | Yes |
| Shear Bond Strength to | |||
| Zirconia (MPa) | 11.2 | 2.8 | 3.8 |
| Flexural strength (MPa) | 125.5 | 170 | 151 |
| Solubility (µg/mm3) | LOW | LOW | LOW |
| Working time at 22°C (min) | 4.5 | 4 | 2.5 |
| Setting time at 37 °C (min) | 2.5 | 3 | 4 |
| Film thickness (µg/mm3) | 10 | 10 | 10 |
| Shelf life (Years) | 2 | 2 | 2 |
| Shear Bond Strength to | |||
| Zirconia (MPa) | 11.2 | 2.8 | 3.8 |
TotalC-Ram is similar to the predicate devices in that they are all auto-mixing, dualcuring, radio-opaque, self-etch and self-adhesive resin cements to be used for permanently cementing restorations such as posts, crowns, bridges, inlays and onlays.
The subject device and the predicate devices have substantially equivalent physical and mechanical properties. As depicted above, the values for the shear bond strength between the subject device and zirconia demonstrate significantly higher values for the subject device. The indication for use for TotalC-Ram mentions specifically the use for ceramics cementation (including zirconia). The differences in the indications for use affect neither the intended use nor substantial equivalence.
TotalC-Ram is different from the predicate devices in that it contains the same key biocompatible ingredients, but in different proportions. The differences in the indications for use affect neither the intended use nor substantial equivalence.
5
10. Indication for Use:
The device is intended for the permanent cementation of ceramic (including zirconia), composite and metal-based posts, crowns, bridges, veneers, inlays and onlays. Below is a comparison of the indications for use of the subject device and the predicates:
| | Subject Device
(Shade Dentin
Base) | Predicate Device
TotalCem | Predicate Device
DentoCem |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use: | for the permanent
cementation of
ceramic (including
zirconia), composite
and metal-based
posts, crowns,
bridges, veneers,
inlays and onlays | for the cementation of
posts, crowns,
bridges, inlays and
onlays. | intended for
permanent
cementation of:
crowns and
bridges, inlays,
onlays, posts and
cores, ceramic
crowns, Maryland
bridges and
veneers;
implant prosthesis;
orthodontic
attachments;
amalgam
restorations;
veneering of
alloys; and
composite
restorations. |
The indication for use for TotalC-Ram mentions specifically the use for ceramics cementation (including zirconia) as this device demonstrate significantly higher shear bond strength values when used for ceramic cementations. The differences in the indications for use affect neither the general intended use nor substantial equivalence.
Brief Description of Performance and Biocompatibility Testing: This 11. 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 establish substantial equivalent to the predicates and demonstrate conformity with FDA's guidance document entitled Dental Cements - Premarket Notification. August 1998 and the following recognized consensus standards:
6
- ISO 4049 - Dentistry - Dentistry -- Polymer-based restorative materials;
- ISO 7405 Dentistry dentistry evaluation of biocompatibility of medical ● devices used in dentistry;
- ISO 9917-1 Dentistry-- water-based cements part 1: powder/liquid acid-base ● cements; and
- . ISO 10993-5 - Biological evaluation of medical devices - part 5: tests for in vitro cytotoxicity.
TotalC-Ram meets or surpasses requirements set forth therein, notably as regards flexural strength, solubility, film thickness and radiopacity.
12. Clinical Performance Data
Not applicable. Clinical performance testing has not been performed for the subject device.
- Conclusion Drawn: Based on a comparison of intended use and indications for use, physical properties and chemical composition. Itena Clinical concludes that the subject device is substantially equivalent to the predicates (respectively, TotalCem and DentoCem (K121804)).