Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Device Description

Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

AI/ML Overview

This submission does not contain information about an AI/ML device or a medical device that would have acceptance criteria and a study to prove it meets them in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity).

The document is a 510(k) summary for a dental restorative material, ZirBlank-PS and ZirBlank-FS, which are yttrium oxide-stabilized zirconia (Y-TZP) powders/blocks. The purpose of a 510(k) submission for such a device is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove diagnostic performance.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth types) because this type of evaluation is not applicable to this particular device and its regulatory submission.

The "study" mentioned in the document refers to the demonstration of substantial equivalence based on:

Same intended use as predicate devices.
Similar technological characteristics, with well-understood differences.
Well-established materials (components of ZirBlank-PS and ZirBlank-FS have prior successful use in legally marketed devices, including hip implants).
Comparison to predicate devices for safety and effectiveness.

The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence, primarily by demonstrating that the device is as safe and effective as predicate devices. The performance is assessed by material properties and intended use, not by diagnostic accuracy.

Summary

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XI.

510 (k) SUMMARY

Submitter: Dr. Kyung-Bin Lee, Pres. Acucera, Inc., Namyangiu-si, Gyeonggi 472-481, (Seoul) Korea. Phone: 82-(0)31-527-6940.

I. Classification Names and numbers: Porcelain powler for clinical use, EIH, Class II, described in CFR 872.6660.
II. Common/Usual Name: Dental restorative material, porcelain powder/blocks

III. Proprietary Names: ZirBlank-PS and ZirBlank-FS

1070045

IV. Establishment Registration Number: In process

V. Device Description: Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

VI. Substantial Equivalence: ZirBlank-PS and ZirBlank-FS (when it reaches the dentist, like porcelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. Relative to devices currently on the market, cleared by the 510(k) process, ZirBlank-PS and ZirBlank-FS is substantially equivalent to Zerion Alpha; Zerion Beta, cleared in K061804, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000 M cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to Denzir"11 (Dentronic AB) cleared under K984201 as well as Cercon Base™ (Degussa Dental) cleared under K-013230. Like Zerion Alpha & Beta, it is intended to be marketed both as a partially sintered device which will then be machined and fully sintered and in a fully sintered form. Like Austenal's DC Zirkon (001815) it can be used in the DCS CAD/CAM system, and in the CNC milling machine, or other CAD/CAM system meeting the requirements of the recently issued FDA Class II Special Controls Guidance for Optical Impression System... for Dental Restorations.

The successful prior use of the components of ZirBlank-PS and ZirBlank-FS product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of ZirBlank-PS and ZirBlank-FS to prior cleared devices support the safety and effectiveness of the ZirBlank-PS and ZirElank-FS product for the intended use.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, to be cemented/luted into place as inlays, onlays, veneers or crowns and for bridge components the repair of damaged teeth.
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1. The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for slight differences in methods of use. In addition, the technological differences are well understood in the dental industry. The use of a computerized lathe system to prepare the inlay or only, when used in the dental office, also has been cleared by 510(k)--K950299 and K972276 and others.
1. Descriptive information provided shows that the materials from which this device is made are well-established in the more demanding areas of hip implants. They resemble the properties of finished porcelain products and usually will have porcelain finishes.
1. The FDA "Decision-Making Process" char: was used and appears in Appendix V.

[End of Summary]

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Kyung- Bin Lee President Acucera, Incorporated 539 Jinbul-Li Jinjeop, Namyangju Gyeonggi, Republic of Korea 472-861

MAR 2 6 2007

Re: K070045

Trade/Device Name: ZirBlank- PS and ZirBlank-FS Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2006 Received: January 4, 2007

Dear Dr. Bin Lee:

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 - Dr. Bin Lee

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 vours.

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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VIII. Indications for Use: [Separate Page]

510(k) Number: NA

Device Name: ZirBlank-PS and ZirBlank-FS

Indications for use:

Prescription Use X (Per 21 CFR 801 Subpart D ) OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDE!

Concurrence of CDRH, Office of Device Evaluation(ODE)

Susan Runse

f Anesthesia, Department of Anesthesia, General Hospital Hospital
Infection Control, Central Services

Neart Ko20045

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.