This device is intended to manufacture dental prosthesis as artificial crown, bridge and dental core
The device is intended to manufacture crown and bridge porcelainfused-to-metal prostheses and dental cores

Device Description

Dental Porcelain (Glass Powder) Top-Ceram Powder T-1, T1, T2, T3, T4 are composed of Lanthanum oxide (La2O3), Cerium oxide (CeO2), Titanium xide( TiO2), Silicon dioxide (SiO2), Calcium oxide(CaO), Aluminum oxide(Al2O3), Iron oxide(Fe2O3) and they are intended for use by dental technicians for dental prothesis.

AI/ML Overview

This document describes a 510(k) premarket notification for "Dental Porcelain (Glass Powder) Top-Ceram Powder T-1, T1, T2, T3, T4" by Global Top Inc. The submission aims to establish substantial equivalence to a predicate device, K062504 CeraMax marketed by Alphadent Co., Ltd.

The provided text focuses on the administrative aspects of the 510(k) submission, including device description, intended use, and comparison to a predicate device. It explicitly states that the device is equivalent to the predicate device in "*components, *indications for use, *chemical properties, and *performance properties."

However, the provided text does not contain any information regarding specific acceptance criteria, study design, or performance metrics. It does not present a table of acceptance criteria and reported device performance. Therefore, I cannot answer the majority of your questions about the study that proves the device meets acceptance criteria.

Here's what information I can extract based on the provided text, and what I cannot:

1. A table of acceptance criteria and the reported device performance

Cannot provide. The document states that the device is equivalent to the predicate in "performance properties" but does not define these properties, set acceptance criteria, or report any performance data for the Top-Ceram Powder.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot provide. No information on a test set, sample size, or data provenance is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot provide. No mention of experts or ground truth establishment for a test set. This device is a material (dental porcelain), not a diagnostic device that would typically involve expert ground truth for performance evaluation in the way you're asking.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot provide. Not applicable, as there's no test set or adjudication process described.

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

Cannot provide. This device is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant to its evaluation.

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

Cannot provide. Not applicable, as this is not an algorithm or software device.

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

Cannot provide. No information on ground truth is provided. For a dental material, "ground truth" would typically relate to material properties (e.g., strength, hardness, biocompatibility), which would be assessed through laboratory testing, not expert consensus in the diagnostic sense.

8. The sample size for the training set

Cannot provide. Not applicable as this is not a machine learning or AI device that requires a training set.

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

Cannot provide. Not applicable.

What the document does indicate:

Device Type: Dental Porcelain (Glass Powder)
Intended Use: To manufacture dental prosthesis as artificial crown, bridge, and dental core.
Comparison Basis: Substantial equivalence to predicate device K062504 CeraMax by Alphadent Co., Ltd.
Equivalence Claims: Based on "components, indications for use, chemical properties, and performance properties." This suggests that the "study" for this type of device typically involves demonstrating similar material characteristics and intended application to a legally marketed predicate, rather than a clinical performance study with human readers or AI.

To obtain the information you are requesting about acceptance criteria and detailed study data, one would need to review the specific performance data and testing protocols that were submitted as part of the K081200 510(k) substantial equivalence determination, which are not included in this summary document. The summary only makes a general statement about equivalence in performance properties.

Summary

{0}------------------------------------------------

Losi Zoo

AUG - 8 2008

Global Top Inc.

#613, Dreamworld B/D 863-1, Janghang-dong, Ilsandong-gu, Goyang-si Gyeonggi-do. Korea Tel: *82-31-9080221 Fax: 082-31-9080224

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:	Global Top Inc#613, Dreamworld B/D 863-1, Janghang-dongIlsandong-gu, Goyang-si, Gyeonggi-do, Korea
Date Summary Prepared:	Apr 14, 2008
Contact Person:	Jeong Chol, Choi / Directoryoudent@naver.com
Device Name:	Dental Porcelain (Glass Powder)
Trade Name(s):	Top-Ceram Powder T-1, T1, T2, T3, T4
Classification Name:	Porcelain Powder for Clinical Use
Panel:	Dental
Product Code:	EIH

Predicate Device Information: K062504 CeraMax marketed by Alphadent Co., Ltd.

Device Description:

Intended Use:

This device is intended to manufacture dental prosthesis as artificial crown, bridge and dental core

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

*performance properties

Conclusions:

Based on the information provided in this premarket notification Global Top Inc concludes that Dental Porcelain (Glass Powder) Top-Ceram Powder T-1, T1, T2, T3, T4 are safe and effective and substantially equivalent to predicate device as described herein.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Global Top, Incorporated C/O Mr. Claude Yang, CEO Onbix Corporation #708 Le-Meilleur Town 837-19 Gangnam-gu Seoul 135-937 REPUBLIC OF KOREA

AUG - 8 2008

Re: K081200

Trade/Device Names: Top Ceram Powder (T-1, T1, T2, T3, T4) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 7, 2008 Received: July 16, 2008

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.

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.

{2}------------------------------------------------

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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Thlomuelo kerdry for

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

510(k) Number (if known): K081200

Device Name: Top Ceram Powder (T-1, T1, T2, T3, T4)

Indications for Use:

The device is intended to manufacture crown and bridge porcelainfused-to-metal prostheses and dental cores

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sua Sunaer

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

510(k) Number: K051026

Page 1 of 1

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.