(103 days)
Not Found
No
The description focuses on the material properties and manufacturing process of the zirconia blocks, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device is a material (zirconia blocks) used to prepare dental restorations (crowns, onlays, bridges) and does not directly provide therapy or treatment.
No
The device is a material (zirconia blocks) used for preparing dental prosthetics like crowns and bridges, not for diagnosing medical conditions.
No
The device is a physical material (zirconia blocks) used in a CAD/CAM milling process, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that Avante Z Zirconia (AS) Blocks are materials used for creating dental restorations (crowns, onlays, bridges). They are milled and sintered to form a physical dental device.
- Intended Use: The intended use is for the preparation of dental restorations, not for testing biological samples.
The device is a material used in the manufacturing of a medical device (dental restorations), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Avante Z Zirconia (AS)3 Blocks consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).
Product codes
EIH
Device Description
Avante Z Zirconia (AS) Blocks are partially sintered yttriastabilized zirconia blocks for use as CAD/CAM milling blanks. They are in a chalk-like state and can be milled using anv compatible CAD/CAM machine such as Sirona InLab (Sirona Dental Systems, LLC. Charlotte, NC) or KaVO Everest (Ka Vo Dental, Lake Zurich, IL). It is necessary to mill the blocks with an enlargement factor to account for the shrinkage that occurs during sintering. After the block is milled, it is sintered which causes the material to densify into a high strength ceramic suitable for dental inllays, onlays, crowns, and bridges.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
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5.0 510(k) SUMMARY
SEP 3 0 2008
- Submitter: Pentron Ceramics, Inc. 500 Memorial Drive Somerset, NJ 08873 (732) 563-4755 (732) 563-1120 (fax)
- Contact: Cindy Salter, QA/RA Manager
- Date Prepared: June 14, 2008
- Trade Name: Avante Z Zirconia (AS)3 Blocks
- Classification Name: Porcelain Powder for Clinical Use (872.6660)
- Predicate Devices: IPS e.max ZirCAD by Ivoclar Vivadent AG (K051705) Zeno Zr Disc by Wieland Dental+Technik Gmbh&Co KG (K073108)
- Device Description: Avante Z Zirconia (AS) Blocks are partially sintered yttriastabilized zirconia blocks for use as CAD/CAM milling blanks. They are in a chalk-like state and can be milled using anv compatible CAD/CAM machine such as Sirona InLab (Sirona Dental Systems, LLC. Charlotte, NC) or KaVO Everest (Ka Vo Dental, Lake Zurich, IL). It is necessary to mill the blocks with an enlargement factor to account for the shrinkage that occurs during sintering. After the block is milled, it is sintered which causes the material to densify into a high strength ceramic suitable for dental inllays, onlays, crowns, and bridges.
- Avante Z Zirconia (AS)3 Blocks consists of machinable zirconia Intended Use: blocks for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).
- Technological Characteristics: All of the components of Avante Z Zirconia (AS) Blocks have been used in legally marketed devices. The formulations have not been changed in any way that may adversely impact safety or efficacy.
Image /page/0/Picture/12 description: The image shows the logo for Pentron Ceramics Inc. The text below the logo reads "510K Submission - Avante® Z Zirconia (AS) Blocks". The logo is in black and white, and the text is in black.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side.
Food and Drua Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2008
Ms. Cindy Salter Quality Assurance/Regulatory Affairs Pentron Ceramics, Incorporated 500 Memorial Drive Somerset, New Jersey 08873
Re: K081749
Trade/Device Name: Avante Z Zirconia (AS) Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 19, 2008 Received: September 23, 2008
Dear Ms. Salter:
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. Salter
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,
Mtmuele Xudimy
PRH
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
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4.0 INDICATIONS FOR USE STATEMENT
Avante Z Zirconia (AS) 3 Blocks consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays, and multi-unit bridges and inlay bridges (anterior and molar).
Susan Russer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081749
Image /page/3/Picture/6 description: The image shows the word "Pentron" in a bold, sans-serif font. The word is black and appears to be the name of a company or product. There is a registered trademark symbol next to the "n" in "Pentron". The image is a close-up of the word, and the background is white.
510K Submission – Avante® Z Zirconia (AS)* Blocks