Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Device Description

Dental Porcelain Zr Dental block is composed of ZrO2, YfO2, Y2O3, Al2O3 and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%) and they are intended for use by dental technicians for dental prothesis.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zr Dental block, but it's important to note a significant limitation:

The provided submission document (K093571) for the Zr Dental block is a 510(k) Premarket Notification. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a standalone study with detailed statistical analysis.

Therefore, many of the requested points below (especially those related to sample sizes, ground truth, expert consensus, and MRMC studies) are not typically included or required in a 510(k) summary for this type of device. The document emphasizes comparison of chemical and performance properties to a predicate device.

Here's the information extracted and interpreted based on the content available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from predicate)	Reported Device Performance (Zr Dental block)
Intended Use	CAD/CAM fabrication of all ceramic dental restorations (inlays, onlays, veneers, crowns, and bridges)	CAD/CAM fabrication of all ceramic dental restorations (inlays, onlays, veneers, crowns, and bridges)
Components	(Implicitly similar to predicate: ZrO2, YfO2, Y2O3, Al2O3, SiO2, Fe2O3, TiO2, MnO2, Na2Q)	ZrO2, YfO2, Y2O3, Al2O3, and other material (SiO2(≤0.16%), Fe2O3(≤0.05%), TiO2(≤0.04%), MnO2(≤0.002%), Na2Q(≤0.001%))
Indications for Use	(Identical to intended use)	Identical to intended use.
Chemical Properties	Similar to predicate (K083201 Zmatch Block)	Similar to predicate (K083201 Zmatch Block)
Performance Properties	Similar to predicate (K083201 Zmatch Block)	Similar to predicate (K083201 Zmatch Block)

Notes on Acceptance Criteria: For a 510(k), the "acceptance criteria" are largely an demonstration that the new device is "substantially equivalent" to an existing predicate device. The document does not specify quantitative thresholds or performance metrics that the Zr Dental block must meet in isolation. Instead, it asserts equivalence in categories like "chemical properties" and "performance properties" to the predicate. The direct numerical values for the constituent materials (e.g., SiO2 ≤ 0.16%) can be considered de-facto acceptance criteria for chemical composition, aligning with what would be acceptable for such a device.

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

Sample Size: Not specified. The submission likely relies on internal testing to confirm chemical composition and physical properties, but a specific "test set" in the context of clinical studies or image analysis is not mentioned because this is a material device, not an AI or imaging device.
Data Provenance: Not specified. Testing would typically be conducted by the manufacturer (Ams Co., Ltd.) in Korea. The submission is from Korea. The data would be prospective in the sense that the manufacturer tested their product.

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

Not Applicable. This is a dental material, not a diagnostic or interpretative device that requires expert ground truth establishment in the traditional sense of medical image analysis or clinical outcomes. Material properties are verified through laboratory tests and analytical chemistry, not expert consensus.

4. Adjudication method for the test set

Not Applicable. See point 3.

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

No. This is not an AI-assisted diagnostic device, so MRMC studies are not relevant.

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

Not Applicable. This is a material itself, not an algorithm. Its performance is inherent to its physical and chemical properties when fabricated into a restoration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Laboratory Testing/Analytical Chemistry: For a dental block, "ground truth" would be established through standard laboratory methods (e.g., elemental analysis, mechanical strength testing, biocompatibility assays) to determine its chemical composition and physical characteristics, and then comparing these against established industry standards or the predicate device's known properties.

8. The sample size for the training set

Not Applicable. This is a manufactured material, not a machine learning algorithm. It does not have a "training set" in that context. The material's formula and manufacturing processes are developed based on materials science principles and iterative refinement, not statistical training data.

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

Not Applicable. See point 8.

Summary of the Study (as presented in a 510(k) summary):

The "study" for this 510(k) is primarily a comparative analysis demonstrating "substantial equivalence" of the Zr Dental block to a predicate device (K083201 Zmatch Block). The submission asserts that the new device is equivalent in:

Intended Use: Both are for CAD/CAM fabrication of all ceramic dental restorations (inlays, onlays, veneers, crowns, and bridges).
Technological Characteristics: This includes components, chemical properties, and performance properties. The document explicitly lists the chemical composition of the Zr Dental block.

The "proof" is the assertion by the submitter that based on the provided information (likely internal technical data and comparisons not fully detailed in the public summary), the device is safe, effective, and substantially equivalent to the predicate. The FDA's review of the 510(k) confirms this substantial equivalence. No specific standalone clinical trial or deeply detailed performance study is presented in this summary document to quantitatively define and meet distinct acceptance criteria beyond the qualitative comparison to the predicate.

Summary

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K093571

Ams Co., Ltd.

MAR 1 2 2010

1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea (429-850) Tel: *82-31-4311751 Fax: 082-31-4021751

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information: Ams Co., Ltd. 1284-3 Joungwang-dong, Siheung-si, Kyunggi, Korea Tel: *82-31-4311751 Fax: 082-31-4021751

Date Summary Prepared: Feb 19, 2010

Contact Person: Tae Choung Son / president info@ams.bz

Device Name:

北京

・・・

Trade Name(s): Zr Dental block Classification Name: Porcelain Powder for Clinical Use Panel: Dental Product Code: દાન

Predicate Device Information:

K083201 Zmatch Block manufactured by Dentam Company. Limited

Device Description:

Intended Use:

Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in intended use and technological characteristics, including:

*components

*indications for use

Chemical Properties

원동이다.

chemical properties * performance properties

Conclusions:

Based on the information provided in this premarket notification Ams Co., Ltd concludes that Zr Dental block is safe and effective and substantially equivalent to predicate device as described herein.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes above a wavy line.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR 1 2 2010

AMS Company, Limited C/O Mr. Claude Yang Chief Executive Official Onbix Corporation #708 Le-Meilleur Town, 837-19 Gangnam-Gu Seoul Republic of Korea 135-937

Re: K093571

Trade/Device Name: Zr Dental Block Regulation Number: 21CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 28, 2010 Received: March 9, 2010

Dear Mr. Yang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Yang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/ default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K093571

Indications for Use

510(k) Number (if known): j

Device Name: Zr Dental block

Indications for Use:

. 19-18'90 08

Zr Dental block is intended for CAD/CAM fabrication of all ceramic dental restorations. This device is used for manufacturing of inlays, onlays, veneers, crowns and bridges

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBetz DOS for Dr. K.P. Muly

Division Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices

; 10(k) Number: K093571

OOb

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.