It is intended for: 1) quick temporary cementation of temporary crowns and bridges; 2) rebasing of crowns; and 3) 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.

Device Description

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.

AI/ML Overview

This K122549 510(k) summary describes a dental device called DentoTemp. The submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents and international standards. This type of submission is typically used for devices that are well-understood and for which performance standards and test methods are well-established.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for DentoTemp are directly aligned with its technological characteristics and intended uses, compared against a predicate device (Premier Implant Cement K033309) and relevant standards.

Table of Acceptance Criteria and Reported Device Performance:

Technological Characteristics	Acceptance Criteria (Aligned with Predicate and Standards)	Reported Device Performance (DentoTemp)
Type	Long term temporary Cement	Long term temporary Cement
Intended Use	1. Quick temporary cementation of temporary crowns and bridges; 2. Rebasing of crowns; 3. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired.	1. Quick temporary cementation of temporary crowns and bridges; 2. Rebasing of crowns; 3. Permanent cementation of implant-retained crowns and bridges while maintaining retrievability, when desired.
Working time (sec)	Approximately 90s	90-120s
Solubility (µg/mm³)	Low	Low
Setting time at 37 °C (min)	Approximately 4-5 min	2.5-3 min
Film thickness (µg/mm³)	15 µg/mm³	15 µg/mm³
Shelf life (Years)	2 years	2 years
Linear Shrinkage (%)	2.5%	2.5%

Note on "Acceptance Criteria" for Functional Properties: The document implies that meeting or improving upon the predicate device's performance, as well as conforming to relevant standards (ISO 4049 and FDA guidance), constitutes the acceptance criteria. For quantitative metrics like working time, setting time, film thickness, and linear shrinkage, the values of the predicate device serve as benchmarks. For qualities like "low solubility," the standard or common understanding within the industry for temporary dental cements determines acceptance.

Study Information

The provided document describes an Abbreviated 510(k) submission. This means that extensive, novel clinical trials demonstrating effectiveness may not have been performed in the same way as for a completely new technology. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Premier Implant Cement, K033309) by adhering to established performance standards and guidance documents.

Here's what can be inferred or directly stated about the "study" based on the provided information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not provide details on specific sample sizes for particular tests. As an Abbreviated 510(k), it relies on conformity with established standards (ISO 4049) and FDA guidance for dental cements. These standards dictate specific test methods and often include requirements for sample sizes, but these are not explicitly presented here as "test set" samples for a novel study.
- The data provenance is not specified beyond "Itena Clinical has provided information to demonstrate conformity." It's likely these tests were performed in a lab setting to ISO standards, but the location is not further detailed. The submission came from France.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable in the context of this submission. The "ground truth" for the performance characteristics of a dental cement like DentoTemp is established by universally recognized physical and chemical testing methods outlined in standards such as ISO 4049, not by expert consensus on clinical cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes where an expert panel provides a gold standard. For material property testing of a dental cement, the "adjudication" is inherent in the standardized test methods and measurement protocols.
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:
- This is not applicable. MRMC studies and the concept of "human readers improving with AI assistance" are relevant to diagnostic AI devices, particularly in medical imaging. DentoTemp is a dental cement, a material device, and does not involve AI or human interpretation in this manner.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This question pertains to AI/algorithm performance. DentoTemp is a material device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance characteristics (e.g., working time, setting time, film thickness, solubility, linear shrinkage, shelf life) is established through standardized laboratory testing methods as specified in ISO 4049 and likely FDA guidance documents for dental cements. The results of these tests (e.g., a measured working time of 90-120 seconds) directly represent the "truth" of the material's properties under specified conditions.
The sample size for the training set:
- This is not applicable. "Training set" refers to data used to train machine learning models. As DentoTemp is a material device, there is no AI or machine learning involved, and thus no training set in this context.
How the ground truth for the training set was established:
- This is not applicable for the same reasons as #7.

In summary, the "study" for K122549 is a non-clinical performance evaluation demonstrating that DentoTemp's physical and chemical properties conform to recognized industry standards (ISO 4049) and FDA guidance for dental cements, and that these properties are substantially equivalent to those of the predicate device. This approach is standard for Abbreviated 510(k) submissions for well-understood material devices like dental cements.

Summary

{0}------------------------------------------------

K122549

Abbreviated 510(k) Summary

APR 2 6 2013

1. Name/Address of Submitter:
  Itena Clinical 83 avenue Foch 75116 Paris FRANCE

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.
1. 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 ImplantCement
		K033309

{1}------------------------------------------------

Type	Long term temporary Cement	Long term temporary Cement
Intended Use	It is intended for:1) quick temporary cementationof temporary crowns andbridges;2) rebasing of crowns; and3) permanent cementation ofimplant-retained crowns andbridges while maintainingretrievability, when desired.	is a non-eugenol temporarycement 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

Regulation Number and Section

§ 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.