(74 days)
Not Found
No
The summary describes a pre-formed material for dental prosthetics and bases equivalence on material properties and intended use, with no mention of AI/ML or related concepts like image processing or performance studies typical of AI/ML devices.
No
The device, Ceramill Zi blanks, is a material used in the manufacture of dental prosthetics, which are considered medical devices but not therapeutic in nature. The justification explicitly states that no performance studies were required, as it is based on comparisons of formulations, mechanical characteristics, and intended uses of the device to legally marketed predicates and identification of porcelain powders. This indicates it is a material component, not a device that directly treats or prevents a disease or condition.
No
Explanation: The device is a pre-formed material used to manufacture dental prosthetics, not to diagnose a condition.
No
The device description clearly states it is a "pre-formed material," indicating a physical component, 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 "in the manufacture of dental prosthetics." This is a manufacturing process for a medical device (dental prosthetics), not a diagnostic test performed on a sample from the human body to provide information about a physiological state, health, or disease.
- Device Description: The device is a "pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics." This describes a raw material used in a manufacturing process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Comparison to Predicate Devices: The predicate devices listed are also materials used in the manufacture of dental prosthetics, not IVDs.
- Regulatory Identification: The comparison to the "IDENTIFICATION of porcelain powders in 21 CFR 872.6660" further indicates it falls under the category of dental materials, not IVDs.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is a material used to create a prosthetic that will be placed in vivo (inside the body).
N/A
Intended Use / Indications for Use
Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The Ceramill Zi Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
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
Not Found
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, mechanical characteristics, and intended uses of the 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KaVo Everest ZS-Blank K03281, 3M "Lava" K053438, Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130, ZIRKONZAHN GMBHZIRKONZAHN ICE K061851
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB - 2 2007
EXHIBIT 2 510(k) SUMMARY: Amann Girrbach America, Inc. Ceramill Zi Blanks
This 510(k) summary of safety and effectiveness for Amann Girbach America, Inc. Ceramill Zi Blank 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: Amann Girrbach America, Inc
- Address: 12169 Villa Road Spring Hill, FL 34609 Tel 800 851-3719 Fax 352-398-1409 Contact Person: Ms. Amanda Clark
- Manufacturer: Amann Girrbach GmbH Herschaftsweisen 1 Koblach 6842-A Austria
Preparation Date: November 16, 2006
Device Name: Ceramill Zi Blank Common Name: Dental Frame Material for Dental Prosthesis Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76
- Predicate devices: KaVo Everest ZS-Blank K03281 and 3M "Lava" K053438 and Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN ICE K061851, among others.
- Device description: The Ceramill Zi Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
- Indications: The Ceramill Zi Blank is used in the manufacture of dental prosthetics.
- Performance Data: None required. The claim of substantial equivalence is based on comparisons of formulations, mechanical characteristics, and intended uses of the 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 Amann Girrbach America, Inc believes that Ceramill Zi Blank is substantially equivalent to cited legally marketed predicates and to the IDENTIFICATION in the classifying regulation (21 CFR 872.6660).
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is black and has a simple, modern design. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amann Girrbach America, Incorporated C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield Illinois 60015
FEB - 2 2007
·Re: K063511
Trade/Device Name: Ceramill Zi Blanks Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 16, 2006 Received: November 21, 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. Kamm
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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KOlo 35) 510(k) Number (if known):
Device Name: Ceramill Zi blanks .
Indications for Use:
Amann Girrbach America, Inc. Ceramill Zi blanks are used in the manufacture of dental prosthetics.
Prescription Use C (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Runse
( ग्राहाज्या (आहे. 18) Onvision of Anonhestology Forneral Hospital I Tarilon Control, Dental Devices
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