FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.
The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.

Device Description

The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.
FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.
The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.

AI/ML Overview

The provided text is a 510(k) summary for a dental device called "FixTemp C&B". This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.

Therefore, many of the requested elements for an AI/software device are not applicable to this submission. This is a traditional medical device submission, not a software as a medical device (SaMD) submission.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable:

Acceptance Criteria and Device Performance for FixTemp C&B

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from ISO 10993/ASTM Standards where stated)	Reported Device Performance (FixTemp C&B)
Biocompatibility
Cytotoxicity	Not cytotoxic (based on Agar Diffusion Test, Din EN ISO 10993-5, using L929 mouse fibroblasts).	Met criteria of the test and was found to be non-cytotoxic.
Sensitization	Did not induce sensitization (based on modified Guinea Pig Maximization Test (GMPT), ASTM F720-81).	Did not induce any sensitization.
Genotoxicity	Non-mutagenic (based on Ames test, with or without metabolic activation).	Fixtemp C&B (extract) was non mutagenic in the Ames test either with or without metabolic activation.
Carcinogenicity	Not required if negative genotoxicity/cytotoxicity and low exposure.	Not conducted as not thought necessary due to extraordinarily low exposure levels and negative genotoxicity and cytotoxicity tests, conforming to general plastics testing procedures.
Implantation	Not required if contact only with hard/surface soft tissues (DIN EN ISO 10993).	Not conducted as material only comes into contact with oral hard tissues and the surface of oral soft tissues when used as prescribed.
Acute Systemic Toxicity	Not explicitly obligatory per DIN EN ISO 10993; components with >3% content have low acute oral toxicity and are generally used in dental materials.	Not specifically evaluated. Components with >3% have very low acute oral toxicity and are approved for use in dental materials by FDA.
Inhalation Toxicity	Not required if practically no volatile compounds and not used as aerosol (FDA G95-1 memo).	Not thought useful and not conducted as it contains practically no volatile compounds and is not used as an aerosol.
Functional/Other
Radiopacity	(Implicitly, to allow easy radiographic identification)	Contains methacrylate components and is radiopaque for easy radiographic identification.
Suitability for Use	Form suitable structure for short and long-term crown and bridge temporaries.	Provides a dental material to short and long term dental provisional prosthetics.
Compatibility	Compatible with light cured composites for repair and characterization.	Compatible with light cured composites for repair and characterization.

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

Sample Size: Not specified in the provided text. For biocompatibility tests, sample sizes are typically standardized by the test methods (e.g., number of cell cultures, animals) but specific numbers are not given here.
Data Provenance: Not explicitly stated but implied to be from laboratory bench testing. No mention of country of origin or whether clinical (retrospective/prospective) data was used, as this is a material science device, not a data-driven AI device.

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

Not Applicable. This is a material testing submission. "Ground truth" in the context of expert consensus is relevant for diagnostic AI systems, not for biocompatibility testing of dental materials. Biocompatibility results are based on objective laboratory measurements and biological responses defined by standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations in diagnostic studies, particularly in AI performance validation. This is not relevant to chemical and biological material testing.

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

Not Applicable. An MRMC study is designed to evaluate human reader performance, often with and without AI assistance, in interpreting medical images or data. This is irrelevant for a dental material (Crown & Bridge Temporary resin).

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not Applicable. There is no algorithm or software component described that would require a standalone performance study.

7. Type of Ground Truth Used

Laboratory Test Results / Standardized Biological Responses: The "ground truth" for the device's performance is established by the results of standardized biological and chemical tests (e.g., cytotoxicity assays, sensitization tests, genotoxicity assays) performed according to international standards (e.g., ISO 10993 parts, ASTM F720-81). These tests provide objective measures of the material's interaction with biological systems.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" as this is a medical device clearance based on material properties and substantial equivalence, not a machine learning model.

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

Not Applicable. See point 8.

Summary

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510(k) Summary (per 21 CFR 807.92)

102917

1) Applicant Information

10 May 2011 Sponsor Mr. Chase Wade EXACTA Dental Direct, Inc. . 44780 Macomb Industrial Dr. Clinton Township MI 48036 800-474-7665 / f- 416 322 7735 chase@exactadental.com

Establishment registration No.

2) General Device Information

Proprietary Name: Trade Name: Common Name Device Classification Name Classification Number: Product Code Review Advisory Committee Classification Advisory Committee Device Classification

Consultant

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

1836392

FixTemp C&B 1m FixTemp C&B ™ FixTemp C&B ™ Crown and Bridge Temporary resin. 21 CFR 872.3770 EBG Dental Dental Class II (nonexempt)

3) Predicate Device

FixTemp C&B "" is substantially equivalent to other legally marketed devices in the United States. FixTemp C&B "" functions in a manner similar to and is intended for the same use as the original Temphase "" formulation that was manufactured by Kerr Dental Materials Center.

Predicate Device	Temphase tm, Temporary Dental Restorative Material.See K020092..Kerr Dental Materials Center1717 West Collins AvenueOrange, California 92867Colleen Boswell
Predicate Device for K020092	Kerr Corporation, TempFil C&B

Trademark Notice: All Trademarks used other than those of EXACTA Dental Direct, Inc. are registered to their respective owners.

4) Device Description

The FixTemp C&B *** is a Class II (nonexempt) device that is ideal suited as a dental acrylic to fabricate temporary crown and bridges.

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EXACTA Dental Direct, Inc.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Page .	FixTemp C&B um

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5. 510(k) Summary

(per 21 CFR 807.92)

FixTemp C&B "" provisional material is a two component, catalyst and base, material dispensed and mixed by a industry standard cartridge/static mixing tip combination. FixTemp C&B "" is intended for . use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. FixTemp C&B "" contains methacrylate components and is radiopaque for easy radiographic identification.

The scientific concept on which this device is based is the principle that ethoxylated Bis-GMA is a multifunctional acrylates and inorganic fillers as silinated barium glass and silinated silicic acid to form a suitable structure for a short and long term crown and bridge temporaries. This device functions by providing a dental material to short and long term dental provisional prosthetics.

5a) Intended Use

The intended use of the FixTemp C&B "" is to form short and long term dental provisional prosthetics.

5b) Comparison to Predicate

EXACTA Dental Direct, Inc. has determined that the FixTemp C&B "" device is substantially equivalent to the performance of the predicate device. The differences between our device and the predicate is incidental and not significant. Both our device and the predicate have the same technological and chemical characteristics.

The FixTemp C&B"" device has the same technological characteristics when compared to the predicate device:

. The Indications for Use for the FixTemp C&B *** device is identical to the Temphase 100, Temporary Dental Restorative Material.
The Operational principals are the same. ●
Manufacturing materials and processes are similar. .

Any differences do not affect the safety and effectiveness of the device when used as labeled.

5c) Bench Tests

The following bench tests were conducted.

Cytotoxicity.

Cytotoxicity test was performed as Agar Diffusion Test with cured material, according to Din E N ISO 10993-5 (DIN/EN 30993-5). The recommended cell strain L929 (mouse fibroblasts) was used. Fixtemp C&B met the criteria of the test and was found to be non-cylotoxic.

Sensitization.

The potential for sensitization of Fixtemp C&B was tested with a modified Guinea Pig Maximization Test (GMPT) according to Magnusson and Kligman (ASTM standards, Standard Practice F720-81), Under the test conditions, Fixtemp C&B did not induce any sensitization,

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EXACTA Dental Direct, Inc.	Page 2	FixTemp C&B "m

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5. 510(k) Summary

(per 21 CFR 807.92)

Genotoxicity (Arnes-Test)

Fixtemp C&B was tested with an Ames test for its genotoxic potential.

Fixtemp C&B (extract) was non mutagenic in the Ames test either with or without metabolic activation,

Carcinogenicity.

A test for carcinogenicity was not conducted, as this test is only sensible according to DIN EN ISO 10993, if there are hints for such a suspect. in view of the extraordinarily low exposition levels and the negative genotoxicity and cytoxicity tests a test for carcinogenicity was not thought to be necessary. This conforms with procedures, that are generally applied for the testing of plastics.

Implantation.

Implantation of materials into the muscular tissue of rabbits is done to assess negative reactions of tissue towards biomaterials. If Fixtemp C&B is used as prescribed, the material only comes into contact with oral hard tissues and the surface of oral soft tissues. Therefore no implantation test for Fixtemp C&B was conducted,

Acute Systemic Toxicity.

The acute systemic toxicity is not explicitly obligatory according to DIN EN ISO 10993 and therefore was not specifically evaluated. Assessment of components In Fixtemp C&B that amount to more than 3%, have all a very low acute oral toxicity. They are generally used in dental materials in similar or even higher closes, which have already been reviewed and approved by the FDA,

Inhalation Toxicity.

Fixtemp C&B contains practically no volatile compounds and is not used as an aerosol. Therefore a test for inhalation toxicity, as suggested by the FDA G95-1 memorandum, was not thought useful and therefore was not conducted

Test Conclusion

Different in vivo and in vitro tests of Fixtemp C&B according to DN EN ISO 10993 have proven Fixtemp C&B to be not cytotoxic, not genotoxic and not sensitizing.

Summary

Based on the information, FixTemp C&B "" is substantially equivalent to Temphase "".

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102917 4. Indications for Use Statement

510(K) Number (If known): no 510(K) number assigned Device Name: FixTemp C&B 'm

Indications for Use

FixTemp C&B ™ is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

U S.A. Federal Law restricts the dispensing of device except on the order of a licensed practitioner.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	XXX
	or
	Over - The - Counter Use
	(Per 21 CFR 801.109)
	(Optional Format 1-2-96)

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		FixTemp C&B 'm
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure. The logo is black and white.

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

JUN 1 7 2011

Exacta Dental Direct, Incorporated C/O Mr. Richard Keen Vice President Operations Compliance Consultants 1151 Hope Street Stamford, Connecticut 06907-1659

Re: K102917

Trade/Device Name: Temphase™ Temporary Dental Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 23, 2011 Received: June 1, 2011

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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Page 2- Mr. Keent

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.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,

Anthony D. nater

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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102415 4. Indications for Use Statement

510(K) Number (If known): ____________________________________________________________________________________________________________________________________________________ no 510(K) number assigned Device Name: FixTemp C&B ""

Indications for Use

FixTemp C&B "" is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

U S.A. Federal Law restricts the dispensing of device except on the order of a licensed practitioner.

Susan Runnes

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

510(k) Number: K102

K102917

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseXXX	Or	Over - The - Counter Use(Per 21 CFR 801.109)
		(Optional Format 1-2-96

EXACTA Dental Direct, Inc.	Page 7
	FixTemp C&B ""

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.