(248 days)
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No
The document describes a dental cement and does not mention any AI or ML components or functionalities.
No
The device is a temporary dental cement used for temporary and permanent cementation of crowns and bridges, which is a restorative rather than a therapeutic function.
No
The device is described as a temporary cement for crowns and bridges, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a "dental long term acrylic-urethane polymer based temporary cement," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in a clinical dental setting for cementing dental restorations (crowns and bridges). This is a direct application within the body (or on a dental prosthesis intended for the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details the chemical composition and properties of a dental cement, which is a material used in a clinical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The device's function is purely mechanical/adhesive.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended for:
- quick temporary cementation of temporary crowns and bridges;
- rebasing of crowns: and
- permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired.
DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
DentoTemp: DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Cements - Premarket Notification, August 1998 and ISO 4049 -- Dentistry - Polymer-based filling, restorative and luting materials.
Based on their indications for use, technological characteristics and comparison to predicate devices, the subject device has been shown to be safe and effective for their intended use. Further, combined with biocompatibility testing and based on a comparison of intended use and indications for use, physical properties and composition, Itena Clinical concludes that the subject device is substantially equivalent to the predicate device (Premier Implant Cement K033309).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K122549
Abbreviated 510(k) Summary
APR 2 6 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: lpmarin@bcf.ca
-
Date Summary Prepared: 3.
July 30, 2012 -
Device Names: DentoTemp 4.
-
Device Classification: II ਹੈ.
-
Common name: Dental Cement 6.
-
Classification Product Code: EMA 7.
-
- Predicate Device:
| DentoTemp | Premier Implant Cement |
|---|---|
| K033309 |
Device Description: 9.
DentoTemp: DentoTemp is a dental long term acrylic-urethane polymer based temporary cement. It does not contain eugenol or zinc oxyde. It is a unique 2-stage polymerization composition which does not harm temporary crowns and does not interfere with permanent cements. The technological characteristics for this subject device are as follows:
| Technological Characteristics | Subject Device | Premier Implant
Cement |
|-------------------------------|----------------|---------------------------|
| | | K033309 |
1
| Type | Long term temporary Cement | Long term temporary Cement |
|---|---|---|
| Intended Use | It is intended for: |
- quick temporary cementation
of temporary crowns and
bridges; - rebasing of crowns; and
- permanent cementation of
implant-retained crowns and
bridges while maintaining
retrievability, when desired. | is a non-eugenol temporary
cement for luting implant-
retained crowns. |
| Working time (sec) | 90-120 | 90 |
| Solubility (µg/mm³) | Low | Low |
| Setting time at 37 °C (min) | 2.5-3 | 4-5 |
| Film thickness (µg/mm³) | 15 | 15 |
| Shelf life (Years) | 2 | 2 |
| Linear Shrinkage (%) | 2.5 | 2.5 |
Statement of Intended Use: 10.
Device Name: DentoTemp
The device is intended for:
-
quick temporary cementation of temporary crowns and bridges;
-
rebasing of crowns: and
-
permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired.
DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.
Brief Description of Clinical and Non-clinical Testing: This submission is an 11. 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 Cements - Premarket Notification, August 1998 and ISO 4049 -- Dentistry - Polymer-based filling, restorative and luting materials.
2
Conclusion Drawn: Based on their indications for use, technological characteristics and comparison to predicate devices, the subject device has been shown to be safe and effective for their intended use. Further, combined with biocompatibility testing and based on a comparison of intended use and indications for use, physical properties and composition, Itena Clinical concludes that the subject device is substantially equivalent to the predicate device (Premier Implant Cement K033309).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2013
Itena Clinical C/O Mr. Louis-Paul Marin Co-President BCF Certification, Incorporated 500 Boul Cartier West Laval, Canada H7V 5B7
Re: K122549
Trade/Device Name: DentoTemp Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 27, 2013 Received: March 29, 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, 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.
4
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runner, DDSMA
for
Digitally signed by Mary S. Runneг -5
DN: C=US, OU.S. Government, ou=HHS,
ou-FDA, ou People, cn=Mary S. Runner -
0092342.19200300.100.1.1-1300087950
Date: 2013.04.26 09:15:02-04'00'
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
5
122549
Indication for Use
Device Name: DentoTemp
Indication for Use: It is intended for:
-
quick temporary cementation of temporary crowns and bridges;
-
rebasing of crowns; and
-
permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired.
DentoTemp is fully compatible with both acrylic and composite (bis-acryl) temporary materials and as a result, is indicated on both natural and metal implants abutments.
Concurrence of CDRH Office of Device Evaluation
Prescription Use _ X_ OR Over-the-counter Use __ (per 21CFR 801.109)
Susan Runner, DDS, MA
Digitally signed by Mary S. Runner -S5
CN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1=1300087950
Date: 2013.04.26 09:14:09 -04'00'
on Bign-Om)
on of Anesthesiology, General Hospital ction Control, Dental Devices
510(k) Number: K