NEO DENTA ZIRCONIA by NEO GROUP LIMITED

Neo Denta Zirconia is a partially sintered zirconia disc, which is vttrium oxide stabilized zirconium dioxide. The disc can be milled into various shapes of prostheses. A CAD/CAM system can be used to produce the prostheses needed from the blank. Neo Denta Zirconia provides an alternate to the gold, porcelain, ceramics and other types of material used in the dental laboratories for dental restoration.

AI/ML Overview

This document describes a 510(k) submission for "Neo Denta Zirconia," which is a relabeled product of "Sagemax Z-Blank." The submission asserts substantial equivalence to the predicate device due to identical technological characteristics.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Details for Neo Denta Zirconia

Based on the provided document, the Neo Denta Zirconia is a relabeled product, and its acceptance criteria and performance are established through equivalence to a predicate device, Sagemax Z-Blank. No independent clinical "study" as you might typically envision for a new device was performed for Neo Denta Zirconia itself. Instead, its safety and effectiveness are established by demonstrating that it is identical in all material aspects to a device already cleared by the FDA.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this device is a relabeled predicate, the acceptance criteria and performance are inherently tied to the predicate device, Sagemax Z-Blank. The document states "The dimensions, the material, the chemical composition and all other properties of Neo Denta Zirconia are the same compared to Sagemax Z-Blank."

Acceptance Criteria Category	Reported Device Performance (Neo Denta Zirconia)
Dimensions	Same as Sagemax Z-Blank
Material	Same as Sagemax Z-Blank
Chemical Composition	Same as Sagemax Z-Blank
Other Properties	Same as Sagemax Z-Blank
Particle Size	Measured by laser scanning (No specific value stated, implies conformity to Sagemax Z-Blank's established performance)
Microstructure	Measured (No specific value stated, implies conformity to Sagemax Z-Blank's established performance)
Surface Condition	Measured (No specific value stated, implies conformity to Sagemax Z-Blank's established performance)
1-CR value (Color)	Determined using Xrite Color i7 and UV Spectrophotometer (No specific value stated, implies conformity to Sagemax Z-Blank's established performance)
Flexural Strength & Toughness	Determined using an Autograph strength test machine (No specific value stated, implies conformity to Sagemax Z-Blank's established performance)

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

Sample Size: Not applicable in the context of an independent clinical study for Neo Denta Zirconia. The "test set" for Neo Denta Zirconia's submission was essentially a comparison to the specifications and performance of the Sagemax Z-Blank.
Data Provenance: The data provenance for Neo Denta Zirconia's submission is derived from the predicate device (Sagemax Z-Blank) and non-clinical laboratory testing performed on Neo Denta Zirconia to confirm its identical nature to the predicate. The document does not specify the origin of Sagemax Z-Blank's data.

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

Not applicable as no independent clinical study with a test set requiring expert ground truth establishment was conducted for Neo Denta Zirconia. The "ground truth" for Neo Denta Zirconia is its direct equivalence to Sagemax Z-Blank.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication in the context of this 510(k) submission.

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 MRMC comparative effectiveness study was done. This device is a dental material, not an AI-assisted diagnostic tool or imaging device. Therefore, questions regarding human reader improvement with AI assistance are irrelevant to this submission.

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

No standalone (algorithm only) performance study was done. This device is a dental material, not an algorithm.

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

The "ground truth" for the substantial equivalence claim is the demonstrated identical technological characteristics (dimensions, material, chemical composition, and other properties) of Neo Denta Zirconia to the predicate device, Sagemax Z-Blank, which was previously cleared by the FDA (510(k) number Z062695). Non-clinical testing (particle size, EDS & X-ray EV, microstructure, surface condition, 1-CR value, flexural strength/toughness) was performed on Neo Denta Zirconia to verify these characteristics match the predicate.

8. The sample size for the training set

Not applicable. As this is a dental material submission based on substantial equivalence to a predicate, there is no "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of submission.

Summary

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510(k) Summary

Mike Adams, Q1D G/F Kaiser 3ra Phase, 18 Man Lok Street, Hung Hom, Submitter: Kowloon, Hong Kong.
l. Classification Names: Porcelain powder for Clinical use, ElH
ll. Requlation Number: CFR 872.6660
III. Common/ Usual Name: Zirconia disc, porcelain material for dental restoration
IV. Proprietary Names: Neo Denta Zirconia
V. Establishment Registration Number: In Process
VI. Device description: Neo Denta Zirconia is a partially sintered zirconia disc, which is vttrium oxide stabilized zirconium dioxide. The disc can be milled into various shapes of prostheses. A CAD/CAM system can be used to produce the prostheses needed from the blank. Neo Denta Zirconia provides an alternate to the gold, porcelain, ceramics and other types of material used in the dental laboratories for dental restoration.
Indication for Use: Remedial Blanks for the Fabrication of Dental Restoration VII.
VIII. Technological Characteristics: Since Neo Denta Zirconia is actually relabeled product of the predicate device, Sagemax Z-Blank, Neo Denta Zirconia shares the same technological characteristic with the product of Sagemax. The dimensions, the material, the chemical composition and all other properties of Neo Denta Zirconia are the same compared to Sagemax Z-Blank. The only difference is the design of the packaging material.
IX. Nonclinical Testing: Particle size was measured by laser scanning, Energy Dispersive Spectrometry (EDS) & X-ray EV for chemical composition, microstructure, surface condition and abnormalities, 1-CR value was determined using the Xrite Color i7 and UV Spectrophotometer, and an Autograph strength test machine for flexural strength and toughness, by determining breakage points in 3 point and biaxial flexural tests.
×. Clinical Testing: Clinical testing was not performed for Neo Denta Zirconia since there is no difference in technological characteristics when compared to its predicate.
XI. Substantial Equivalence: Neo Denta Zirconia is the relabeled product of Sagemax Z-Blank, which is cleared by the 510(k) process with the number Z062695, and with the same intended use with Sagemax Z-Blank. Therefore, Neo Denta Zirconia is substantially equivalent in safety and effectiveness to the predicate device.

OCT 2 1 2013

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

October 21, 2013

Neo Group Ltd. C/O Mr. Mike Adams Director of R&D and Manufacturing Q1D, G/F, Kaiser Estate 3td Phase 18 Man Lok Street, Hung Hom Kowloon, Hong Kong REPUBLIC OF CHINA

Re: K130198

Trade/Device Name: Neo Denta Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 24, 2013 Received: July 29, 2013

Dear Mr. Adams:

We have reviewed vour 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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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 of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary Singuiner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page 3 – Mr. Adams

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Enclosure

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K130198

Indication for Use Statement

510(k) Number (if known): NA

Device Name: Neo Denta zirconia

Indications For Use: Remedial Blanks for the Fabrication of Dental Restoration

Prescription Use _ _ X AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)

Mary S. Runner -S

Susan R DOS, MA 2013.10.21

15:55:08:04'00'

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.