The Fixtemp Cement is designed as a luting cement for temporary dental applications. This dental cement having the active ingredients of zinc oxide does not include Eugenol. This lack of Eugenol does not reduce structural properties but allows a choice among healthcare professionals where Eugenol can cause objectionable results.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a dental cement called FixTemp Cement. This document primarily focuses on establishing substantial equivalence to a predicate device, not on presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in a medical AI context. Therefore, much of the requested information regarding AI device studies (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC studies) is not applicable to this document.

However, the document does contain "acceptance criteria" in the form of performance characteristics used to demonstrate substantial equivalence to a predicate device.

Here's the information that can be extracted or inferred from the provided text, adapted to the request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are the performance characteristics of the predicate device, which the FixTemp Cement aims to match or exceed.

Acceptance Criteria (Predicate Device TempoCem K110759)	Reported Device Performance (FixTemp™ Cement)
Physical Properties (ISO 3107)
Film Thickness: Less than 20 µm	Less than 20 µm
Setting Time: 4 min	Approx. 4 - 7 min
Compressive Strength: 8 MPa	More than 8MPa
Working Time: 1 minute	More than 1 min
Other Characteristics
Compliance to standard: ISO3107	ISO3107
Container: double cartridge or syringe	double cartridge or syringe
Dispenser: injector / syringe	injector / syringe
Paste Ratio: 1:1 ?	1:1
Appearance: Homogeneous and smoothly consistent	Homogeneous and smoothly consistent
Storage: Room temperature, dry (15-25°C)	Room temperature, dry (15-25°C)
Indications for Use: Temporary cementation of crowns and bridges or provisional cementation of crowns and bridges on implant abutments	Indicated for luting of temporary dental prosthesis (crowns, inlays, onlays) (Note: The document also states "Same" for the predicate's full indications, indicating broad equivalence)
Intended Use: Temporary luting and cementation of temporary crowns and bridges	Temporary luting and cementation of temporary crowns and bridges

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document refers to "a series of factory tests" and "testing has confirmed this device meets its product specification," but does not provide details on sample sizes for these tests.
Data Provenance: The tests are referred to as "factory tests," implying they were conducted by the manufacturer, Exacta Dental Direct, Inc. No information regarding country of origin of the data or whether it was retrospective/prospective is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes performance testing of a dental cement, not an AI device requiring expert-established ground truth from images or other medical data. The ground truth for physical properties (like film thickness, setting time) would be based on standardized laboratory measurements.

4. Adjudication method for the test set

Not applicable. See point 3. Performance is based on direct physical measurements against a standard (ISO 3107), not on human adjudication of classification or detection tasks.

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

Not applicable. This document is for a dental cement, not an AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document is for a dental cement, not an AI medical device.

7. The type of ground truth used

The ground truth for the performance characteristics (e.g., film thickness, setting time, compressive strength, working time) is established by physical measurements based on recognized international standards (ISO 3107). These are objective, quantitative measurements.

8. The sample size for the training set

Not applicable. This document does not describe the development of an AI model; therefore, there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

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

June 4, 2015

Exacta Dental Direct Inc. c/o Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 60803

Re: K142446

Trade/Device Name: FixTemp Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 28, 2015 Received: March 6, 2015

Dear Mr. Keen:

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 (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 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/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 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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4. Indications for Use Statement

no 510(K) number assigned_ 510(K) Number (If k K142446 Name: FixTemp™ Cement

INDICATIONS FOR USE

FixTemp ™ Cement is a dental luting agent indicated for:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	XXX
------------------	-----

Over - The - Counter Use
	(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 14	Fixtemp Cement
---------	----------------

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5. 510(k) Summary

(per 21 CFR 807.92)

28 May 2015

Sponsor Mr. John Pankuch President

Exacta Dental Direct, Inc.

44780 Macomb Industrial Dr. Clinton Township, MI 48036 (800) 474-7665 416-253-6060 416-253-1911 Fax john@exactadental.com

Consultant

Mr. Richard Keen Compliance Consultants 1151 Hope Street Stamford, CT 06907-1659 203 329 2700 F 203 329 2345 rkeen@fda-complianceconsultants.com

Proprietary Name: Fixtemp Cement Common Name Fixtemp Cement Device Classification Name Dental Cement Classification Number: 21 CFR 872.3275 Product Code EMA Reviewing Group Dental Devices Panel Device Classification Class II Establishment registration No. Owner/Operator 9043538/ Registration # 1836392 Predicate Device K110759/ TempoCem / DMG USA, Inc. Trademark Notice: All Trademarks used other than those of Exacta Dental Direct, Inc. Exacta

Dental Direct, Inc. are registered to their respective owners.

Device Description

Indications For Use

FixTemp "10 Cement is a dental luting agent indicated for:

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

Intended Use

The intended use of the Fixtemp Cement is as a dental luting agent for use in interim dental restorations to retain temporary restorations.

The scientific concept on which this device is based is the principle that a chemical reaction with zinc oxide forms an adhesive bond to act as a dental luting agent. This device functions by creating adhesion by chemical action.

Fixtemp Cement

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5. 510(k) Summary

(per 21 CFR 807.92)

Substantial Equivalence

Exacta Dental Direct, Inc. has determined that the Fixtemp Cement is substantially equivalent to the performance of a predicate Device. Fixtemp Cement is equal to this predicate. The differences between these devices are incidental and not significant. Both devices use similar technological characteristics and principles.

Testing

The Fixtemp Cement has benefited from design, development, testing and production procedures that conform to ISO 13485 Quality Systems.

Testing has confirmed this device meets its product specification. A series of factory tests are conducted to verify the intended signals are accurate and can maintain performance over its useful life. Testing has established this device is equal to predicate medical device in terms of working time, film thickness, and compressive strength (see comparison table).

Conclusion

There are no substantial differences between the Fixtemp Cement defined in this 510(k) submission and the stated predicate device. This device is equal to predicates currently used in other similar medical devices.

Exacta Dental Direct, Inc. continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting device to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.

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Table 12-1 Substantially Equivalent Comparison to Predicate.doc comparison of the FixTemp ™ Cement to the predicate: TempoCem K110759

Description/Feature	Predicate Device TempoCem K110759	FixTemp Cement	Similarity	Difference	Comment
regulatory requirements
Description	temporary luting cement containing Eugenol that is based on zinc oxide in double cartridges	Eugenol free, temporary luting cement based on zinc oxide in double cartridges		Different	The absence of Eugenol simply eliminates the depression of sensitivity.
Classification Name:	Dental cement	Dental cement	Same		Both devices are dental cements
Classification	II	II	Same		Both devices are subject to same FDA regulation.
Regulation Number	21 CFR 872.3275 (a)	21 CFR 872.3275 (b)	Same		Both are subject to same FDA regulations
Product Code	EMB	EMA		Different	Product codes reflect presence or absence of Eugenol
Difference related to Eugenol	pleasant clove taste oil	Eugenol may inhibit future dental procedures		Different	Some practitioners prefer Eugenol and some avoid it.
Indications for Use	Indicated for temporary cementation of crowns and bridges or provisional cementation of crowns and bridges on implant abutments	Indicated for luting of temporary dental prosthesis (crowns, inlays, onlays)	Same
Intended Use	Temporary luting and cementation of temporary crowns and bridges	Temporary luting and cementation of temporary crowns and bridges	Same
What condition does it treat?	Applied directly on the temporary restoration and into the cavity.	Applied directly on the temporary restoration and into the cavity.	Same

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Table 12-1 Substantially Equivalent Comparison to Predicate.doc comparison of the FixTemp ™ Cement to the predicate: TempoCem K110759

Description/Feature	Predicate Device	FixTemp tm Cement	Similarity	Difference
	TempoCem K110759
characteristics
Compliance to standard	ISO3107	ISO3107	same
container	double cartridge or syringe	double cartridge or syringe	same
Dispenser	injector / syringe	injector / syringe	same
Paste Ratio	1:1 ?	1:1	same
Appearance	Homogeneous andsmoothly consistent	Homogeneous andsmoothly consistent	same
Film Thickness (ISO3107)	Less than 20 µm	Less than 20 µm	same
Setting Time (ISO 3107)	4 min	Approx. 4 - 7 min	same
Compressive strength (ISO3107)	8 MPa	More than 8MPa	same
temporary cement	yes	yes	same
temporary cementation ofprovisional crowns & bridges	yes	yes	same
cementing of semi-permanentcrown or bridges on top ofimplants	yes	yes	same
Meets ISO 3107:2004	yes	yes	same
Working time	1 minute	More than 1 min	same
Storage	Room temperature, dry(15-25°C)	Room temperature, dry(15-25°C)	Same
applications
What is the treatmentenvironment?	Applied directly on thetemporary restoration andinto the cavity.	Applied directly on thetemporary restoration andinto the cavity.	Same
Is device a treatmentdevice?	Yes	Yes	Same
What patient populationdoes this apply?	for temporary tooth filling.to affix dental devicessuch as crowns or bridges,or to be applied to a toothto protect the tooth pulp	for temporary lutingcements to affix dentalprosthesis such as crownsor bridges, inlays andonlays	Same
Anatomical Sites	all human teeth	all human teeth, exceptallergies	Same	Same

Page 129 to 133

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.