(65 days)
Empress, ProCAD
Not Found
No
The 510(k) summary describes dental materials (blanks and powder) and their intended use in manufacturing prosthetics. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The basis for substantial equivalence is material composition and intended use, not algorithmic performance.
No.
The device descriptions indicate that these materials are used in the manufacture of dental prosthetics and restorations, not as the therapeutic devices themselves. They are raw materials used by dental laboratories.
No
The device descriptions indicate that the KaVo Everest G-Blanks and G-Ceram are materials used in the manufacturing of dental prosthetics like inlays, crowns, and onlays. They are not described as being used to diagnose conditions or diseases. Their purpose is for fabrication, not diagnosis.
No
The device description clearly states it is a pre-formed material (G-Blank) and a porcelain powder (G-Ceram), which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "manufacture of dental prosthetics," "inlays, crowns, and onlays." This is a manufacturing process for medical devices that are implanted or used in the mouth, not for testing biological samples to diagnose or monitor a medical condition.
- Device Description: The description clearly states the materials are "pre-formed material" and "porcelain powder" used by dental laboratories to create dental prosthetics. This aligns with manufacturing materials, not diagnostic reagents or instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device falls under the category of dental materials used in the creation of custom medical devices (dental prosthetics).
N/A
Intended Use / Indications for Use
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.
Product codes
EIH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratories and licensed professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Empress, ProCAD
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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).
2
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.
3
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
4
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 |
|---|---|
| ---------------- | --------- |
056