TempoCem is a temporary cement based on zinc oxide / eugenol for automatic mixing. Its low film thickness provides an exceptional fit. TempoCem combines reliable adhesion with easy and clean removal. Excess can be removed easily. TempoCem is offered in different varieties.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental temporary cement called TempoCem. The information focuses on regulatory approval based on substantial equivalence to predicate devices and adherence to an international standard.

Based on the provided text, the following information regarding acceptance criteria and a study proving the device meets these criteria can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for TempoCem, as stated, is that it "meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." The text does not provide a table with specific numerical acceptance criteria from this ISO standard nor specific reported performance values for TempoCem against these criteria.

Acceptance Criteria (from ISO Equivalenoo [likely ISO 3107: Dental zinc oxide/eugenol and zinc oxide/non-eugenol cements - Third Edition])	Reported Device Performance (TempoCem)
Specific requirements of ISO 3107 for dental cements (e.g., film thickness, compressive strength, setting time, solubility, adhesion, etc. - not detailed in current document)	"Meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition." "Low film thickness provides an exceptional fit." "Combines reliable adhesion with easy and clean removal." (Specific numerical performance values are not provided in this document).

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that the 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.'" This typically means that new clinical data or extensive performance data might not be required if the device is substantially equivalent to a legally marketed predicate and adheres to recognized standards.

Sample Size for Test Set: Not specified. The document implies compliance with an ISO standard rather than a specific clinical trial with a defined test set sample size.
Data Provenance: Not specified. The compliance is with an "ISO" standard, which is an international standard, but the location where the tests were conducted or the origin of any data (if external to the standard's methodology) is not mentioned. It is highly likely the data is from in vitro laboratory testing to demonstrate compliance with the standard. The study is not a retrospective or prospective clinical study in the traditional sense described in the context of device performance in humans.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and not provided. The device's substantial equivalence is based on meeting an ISO standard for dental cements and comparison to predicate devices, not on expert-adjudicated ground truth from a test set of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As above, the evaluation is based on compliance with an ISO standard, not a human reader or expert adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. The approval is for a dental cement, not an imaging or diagnostic device that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable to this device. TempoCem is a physical dental cement, not an algorithm or AI system. Its performance is intrinsic to the material properties.

7. Type of Ground Truth Used:

The "ground truth" here is compliance with an international standard (ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition). This standard likely sets forth methodologies and acceptable ranges for various physical and chemical properties of dental cements.

8. Sample Size for the Training Set:

This information is not applicable and not provided. As TempoCem is a manufactured product and not an AI/ML algorithm, there is no "training set" in the context of data science or machine learning.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided. There is no ground truth for a training set in this context.

Summary

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Kil0759

0 March 2011

510(k) Summary

Trade Name:	TempoCem
Sponsor:	DMG USA, Inc.23 Frank Mossberg DriveAttleboro, MA 02703Owner/Operator No. 9005969	JUN 10 2011
Device Generic Name:	TempoCem
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.

Product Description:

DMG USA. Inc.

Abbreviated 510(k) Premarket Notification

Product Indications for Use:

temporary cementation of provisional crowns and bridges ●
cementing of semi-permanent implants .

Predicate Devices:

Substantial equivalence is based on comparison to the dental restorative materials identified below.

Product Name - 3 - 1 - 1 - 1 Predicate Device 610 (k) - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
TempoCem	K970775 (Foremost Dental, Inc)
S&C Provi Cem Esthetic	K091735 (S&C Polymer GmbH)

Safetv and Performance:

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." TempoCem meets the requirements of ISO Equivalenoo in i romanto roude/eugenol and zinc oxide/non-eugenol cements - Third Edition.

Conclusion:

Based on the indications for use, technological characteristics, and comparison to the predicate devices, TempoCem has been shown to be safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DMG USA, Incorporated C/O Ms. Pamela Papineau Regulatory Affairs Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432

JUN 1 0 2511

Re: K110759 Trade/Device Name: TempoCem Regulation Number: 21 CFR 872.3275(a) Regulation Name: Dental Cement - Zinc Oxide-Eugenol Regulatory Class: I Product Code: EMB Dated: March 9, 2011 Received: March 18, 2011

Dear Ms. Papineau:

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.

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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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hh fcc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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9 March 2011
TempoCem

510(k) Number (if known):	K110759
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Page 1 ofDevice Name: TempoCem

Product Indications for Use:

TempoCem is a dental luting agent indicated for:

. temporary cementation of provisional crowns and bridges
cementing of semi-permanent implants .

OR Over-the -Counter Use Prescription Use X (Per 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110759

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.