KAVO EVEREST C-TEMP by KAVO AMERICA

The provided 510(k) summary for the KaVo Everest® C-temp material primarily focuses on demonstrating substantial equivalence to predicate devices based on formulation, intended use, and general material classification rather than presenting a study for device performance against specific acceptance criteria. This class II dental material is evaluated through biocompatibility testing and standard compliance rather than a diagnostic performance study. As such, many of the requested categories related to medical device performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable or explicitly stated in this type of submission.

Below is an attempt to structure the available information as per your request, with explicit notes where information is not provided or not applicable due to the nature of the device and its regulatory submission.

Acceptance Criteria and Device Performance Study for KaVo Everest® C-temp

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Conformance
Biocompatibility	Compatibility with long-term contact to human mucous membranes.	"Biocompatibility testing has been conducted to show compatibility with long term contact to human mucous membranes."	Met
Material Classification	Identification as "Material, tooth shade, resin" under 21 CFR 872.3690.	The device is classified as "Material, tooth shade, resin 21 CFR 872.3690 Class II medical device" and is found substantially equivalent to predicate devices and the IDENTIFICATION of tooth shade, resins in 21 CFR 872.3690. The FDA's final classification is "21 CFR 872.3770 Temporary Crown and Bridge Resin".	Met
Standard Compliance	Meets requirements of DIN IEC 60893.	"Meets the requirements of DIN IEC 60893"	Met
Substantial Equivalence	Demonstrates substantial equivalence to legally marketed predicate devices (KaVo Everest® ZS K032081 and Austenal DC-Tell K001799) based on formulation and intended uses.	"The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates... Based on the information in the notification KaVo America believes that The KaVo Everest® C-temp is substantially equivalent to cited legally marketed predicates..." FDA confirmed substantial equivalence.	Met
Intended Use	For manufacture of temporary dental prosthetics to be worn 12 months or less.	The indication for use is precisely "The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less." This aligns with the specified intended use for substantial equivalence.	Met

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

Not Applicable/Not Provided: This submission focuses on material properties, biocompatibility, and substantial equivalence to legally marketed predicate devices rather than a diagnostic performance study with a test set of data samples. The "test set" in this context would refer to material samples used for the specified laboratory tests (biocompatibility, DIN IEC 60893 compliance), but specific sample sizes are not detailed in the summary. Data provenance would be from laboratory testing procedures by the manufacturer.

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

Not Applicable: For a dental material cleared via substantial equivalence, ground truth as established by clinical experts for a diagnostic performance study is not relevant here. The "truth" is established by laboratory testing standards and comparison to predicate devices, verified by regulatory bodies.

4. Adjudication Method for the Test Set

Not Applicable: As there is no diagnostic test set requiring human interpretation and consensus, no adjudication method (e.g., 2+1, 3+1) is relevant.

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 is a submission for a dental material, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.

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

Not Applicable: This is a dental material, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the KaVo Everest® C-temp is established by:
- Laboratory Testing Results: Demonstrating biocompatibility and conformance to the DIN IEC 60893 standard.
- Material Composition/Formulation: Comparison of the material's constituents to predicate devices deemed safe and effective.
- Intended Use Alignment: Confirming the proposed use case (temporary dental prosthetics for 12 months or less) aligns with predicate devices and regulatory definitions.
- Regulatory Classification: Conforming to the established classification for "Temporary Crown and Bridge Resin" (21 CFR 872.3770).

8. The Sample Size for the Training Set

Not Applicable/Not Provided: This is not an AI/machine learning device that would require a "training set." The development process for a dental material would involve R&D and testing, but not in the context of a training algorithm.

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

Not Applicable: As there is no training set for an algorithm, this question is not relevant.

Summary

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K06 3624

510(k) SUMMARY: KaVo Everest® C-Temp

EER 8 2007

This 510(k) summary for KaVo Everest® C-temp material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	KaVo America
Address:	340 East Main Street
	Lake Zurich, IL 60045

Manufacturer: KaVo Elektrotechnisches Werk GmbH, D-88293, Leutkirch im Allgau Germany

Contact Person: John Miller Telephone: 847-364-3931 Preparation Date of Summary: October 16, 2006 Device Name: KaVo Everest® C-temp Common Name: Dental Frame Material for Dental Prosthesis Classification: Material, tooth shade, resin 21 CFR 872.3690 Class II medical device

Product Code: EBF Panel: 76

Predicate devices:	KaVo Everest® ZS K032081 and Austenal DC-Tell (K001799).
Device description:	The KaVo Everest® C-temp is a pre-formed material for use bydental laboratories in filling orders/prescriptions for dentalprosthetics
Indications:	The KaVo Everest® C-temp is used in the manufacture oftemporary dental prosthetics to be worn 12 months or less.
Performance Data:	Biocompatibility testing has been conducted to show compatibilitywith long term contact to human mucous membranes. The claim ofsubstantial equivalence is based on comparisons of formulationsand intended uses of the KaVo devices to legally marketedpredicates and to the IDENTIFICATION of tooth shade, resins in21 CFR 872.3690. Meets the requirements of DIN IEC 60893
CONCLUSION:	Based on the information in the notification KaVo Americabelieves that The KaVo Everest® C-temp is substantiallyequivalent to cited legally marketed predicates and to theIDENTIFICATION in the classifying regulation (21 CFR872.3690)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KaVo America C/O Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

8 2007 53

Re: K063624

Trade/Device Name: KaVo Everest® C-temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 01, 2006 Received: December 20, 2006

Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Daniel Kamm, P.E.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu S. Lin, PhD
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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Indications for Use

510(k) Number (if known):

Device Name: KaVo Everest® C-temp.

Indications For Use:

The KaVo Everest® C-temp is used in the manufacture of temporary dental prosthetics to be worn 12 months or less.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suna Quape

510(k) Number

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

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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.