KaVo Everest G-Blanks are used in the manufacture of dental prosthetics.
KaVo Everest G-Ceram is used in the manufacture of inlays, crowns, and onlays.

Device Description

The KaVo Everest G-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics; KaVo Everest G-Ceram is a porcelain powder for use by dental laboratories in filling orders/prescriptions of dentists for inlays, crowns, and onlays.

AI/ML Overview

The provided text does not contain information regarding acceptance criteria and the study that proves the device meets the acceptance criteria for a medical device that would typically involve performance metrics and clinical studies. Instead, it is a 510(k) premarket notification summary for dental materials (KaVo Everest G-Blank and KaVo Everest G-Ceram).

For these types of materials, the "acceptance criteria" for regulatory clearance are primarily based on substantial equivalence to legally marketed predicate devices and compliance with relevant regulations and material identifications, rather than performance data from a specific study comparing device output to clinical outcomes.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (from K030607 Summary)
Formulation Comparison: Equivalent to predicate device formulations.	"claim of substantial equivalence is based on comparisons of formulations"
Intended Use Comparison: Equivalent to predicate device intended uses.	"claim of substantial equivalence is based on comparisons of... intended uses of the KaVo devices to legally marketed predicates"
Regulatory Identification: Aligns with the classification regulation (21 CFR 872.6660, Porcelain powder for clinical use).	"IDENTIFICATION of porcelain powders in 21 CFR 872.6660."
Safety and Effectiveness: Assumed to be equivalent to predicate devices, thus not requiring specific performance data for clearance beyond formulation and use comparison.	"Performance Data: None required."

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

Not Applicable. The submission explicitly states "Performance Data: None required." This indicates that no specific test set (clinical or otherwise) with a defined sample size was used to demonstrate performance against acceptance criteria for the purpose of this 510(k) submission. The clearance was based on substantial equivalence to existing devices and their classifications.

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

Not Applicable. As no performance data from a test set was required or provided, there were no experts used to establish ground truth in this context.

4. Adjudication method for the test set:

Not Applicable. No test set or performance study was conducted.

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 device is a dental material, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

Not Applicable. This device is a dental material, not an algorithm.

7. The type of ground truth used:

Not Applicable in the traditional sense. For this 510(k), the "ground truth" for substantial equivalence was established by the pre-existing classification regulation for Porcelain Powder for Clinical Use (21 CFR 872.6660) and the established safety and effectiveness profiles of the cited predicate devices (Empress and ProCAD). The agency determined that the new devices' formulations and intended uses were sufficiently similar to these established entities.

8. The sample size for the training set:

Not Applicable. As no performance data or machine learning components are involved, there is no training set.

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

Not Applicable. As no performance data or machine learning components are involved, there is no training set and thus no ground truth to establish for it.

Conclusion from the document:

The 510(k) clearance for KaVo Everest G-Blank and KaVo Everest G-Ceram was granted based on a demonstration of substantial equivalence to predicate devices (Empress and ProCAD) in terms of:

Formulation
Intended use
Alignment with the existing regulatory classification (21 CFR 872.6660 for Porcelain Powder for Clinical Use).

The submission explicitly states "Performance Data: None required," indicating that no specific clinical or performance studies with acceptance criteria based on metrics like sensitivity, specificity, or effect size were part of the regulatory review process for this device's clearance.

Summary

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K0306007

SECTION 10

510(k) SUMMARY

This 510(k) summary of safety and effectiveness for KaVo Everest G-Blank and Everest G-Ceram materials 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 Corporation

340 East Main Street Address: Lake Zurich, IL 60045
Manufacturer: CHEMICHL, AG Landstrasse 114 P.O. 732 VADUZ, LIECHTENSTEIN GERMANY FL 9490
Ms. Jennifer Pottala Contact Person:
847-550-6800 Telephone: 847-550-6825 (Fax) 800-323-8029

December 2002 Preparation Date: (of the Summary)

KaVo Everest G-Blank, KaVo Everest G-Ceram, and KaVo Everest G-Stain Device Names:

Common Name: Porcelain powder, blanks, and colors/stains/shades

Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76

Predicate devices: Empress and ProCAD

Device description: The KaVo Everest G-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics; KaVo Everest G-Ceram is a porcelain powder for use by dental laboratories in filling orders/prescriptions of dentists for inlays, crowns, and onlays.

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KaVo Everest G-Blank is used in the manufacture of dental prosthetics. Indications:

KaVo Everest G-Ceram is used in the manufacture of inlays, crowns, and onlays.

KaVo proposes that the materials distributed within the United States be labeled:

"CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."

Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations and intended uses of the KaVo devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660.
CONCLUSION: Based on the information in the notification KaVo America believes that KaVo Everest G-Blank, Everest G-Ceram and accessories (KaVo Everest-G Stain) are substantially equivalent to cited legally marketed predicates and to the IDENTIFICATION in the classifying regulation (21 CFR 872.6660).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three abstract profiles merging into one. The profiles are connected by flowing lines, creating a sense of unity and movement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Ms. Jennifer Pottala New Products Manager KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60045

Re: K030607

Trade/Device Name: KaVo Everest G-Blank, KaVo Everest G-Ceram, and KaVo Everest G-Stain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: February 24, 2003 Received: February 26, 2003

Dear Ms. Pottala:

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 - Ms. Jennifer Pottala

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 vour 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susa Runser

Susan Runner, DDS. MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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SECTION 7

INDICATIONS FOR USE STATEMENT

1 0 30 GO 510(k) Number (if known): ________

Device Name: KaVo Everest G-Blank and KaVo Everest G-Ceram

Indications for Use Statement:

KaVo Everest G-Blanks are used in the manufacture of dental prosthetics.

KaVo Everest G-Ceram is used in the manufacture of inlays, crowns, and onlays.

KaVo proposes that the materials, when intended for distribution in the United States, be labeled:

CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use		OR	Over-The Counter Use _
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

for msoz

510(k) Number:	K030607
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056

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.