The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Device Description

ZIROX is a pre-formed machineable dental blank composed of zirconium oxide. ZIROX is available in partially-sintered. ZIROX is available in different shapes, and dimensions, ZIROX has two types that are 51x23x16 and 51x23x18. The only difference between 51x23x16 and 51x23x18 is the size(height).

ZIROX is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations. ZIROX is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.

AI/ML Overview

This 510(k) premarket notification for ZIROX, a porcelain powder for clinical use, does not contain information about acceptance criteria or a study proving that a device meets those criteria in the way typically associated with AI/ML-enabled medical devices. The document is for a dental material (zirconium oxide blank) and focuses on substantial equivalence to predicate devices based on material composition, intended use, and biomechanical properties, rather than performance metrics.

Therefore, most of the requested information regarding acceptance criteria, device performance, study design, expert consensus, and ground truth is not applicable to this submission.

Here's an explanation based on the provided text, highlighting the absence of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This 510(k) submission for a dental material (zirconium oxide blank) does not define specific performance acceptance criteria for an AI/ML component. The submission focuses on demonstrating substantial equivalence to predicate devices based on material characteristics and intended use.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no test set in the context of an algorithmic performance evaluation. The submission refers to a pre-formed machineable dental blank; any "testing" would relate to its physical and chemical properties and biocompatibility, not an AI/ML algorithm's performance on a data set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment in the context of evaluating an AI/ML algorithm's output. The device itself is the material, not an diagnostic or interpretative algorithm.

4. Adjudication Method

Not applicable. No adjudication method is mentioned as there is no diagnostic or interpretive task being evaluated by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance. This submission is for a dental material, not an AI/ML device, so no such study was conducted or is applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a material, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

Not applicable. No ground truth is established for an algorithmic output.

8. Sample Size for the Training Set

Not applicable. There is no training set for an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study (as described in the 510(k) document - focusing on substantial equivalence):

The submission demonstrates substantial equivalence of ZIROX to legally marketed predicate devices rather than proving performance against specific acceptance criteria for an AI/ML component. The "study" (or rather, the basis for clearance) relies on the following:

Comparison to Predicate Devices: ZIROX is compared to Dentsply-Cercon Base (K013230), 3M-LAVA Zirconia (K011394), and Sagemax Bioceramics-Sagemax Z-Blank (K062695).
Identical Intended Use and Material: The document states that ZIROX and the predicate devices are "identical in intended use and material."
Similar Biocompatibility and Biomechanical Strength/Properties: The submission asserts that ZIROX and predicate devices are "biocompatible and have similar biomechanical strength and properties."

This approach to clearance for a device like ZIROX, a dental material, is typical for 510(k) submissions where the device is not an AI/ML software but a physical product.

Summary

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K092630

510(k) SUMMARY

OCT 2 2 2009

Submitter:

Name:
	Carreland Controller
Address:

ZENČERA, INC. Room 1108, ACE Techno Tower 5th Building, 197-22, Guro3-Dong, Guro-Gu, Seoul, Republic of Korea, 152-766

Name:	Haeryang Joo
Address:	4525 Wilshire Blvd., Los Angeles, CA, 90010, U.S.A
Phone No.:	+1-323-935-0606
Fax No.:	+1-323-935-7779
E-Mail:	sylee68@gmail.com

Official Correspondent:

Name:	San-ho Hyun
Address:	Room 1108, ACE Techno Tower 5th Building, 197-22, GuroDong, Guro-Gu, Seoul, Republic of Korea, 152-766
Phone No.:	+82-2-2109-0955
Fax No.:	+82-2-2109-0957
E-Mail:	sanho0517@hanmail.net

Device Identification

Proprietary Name:	ZIROX
Common/Usual Name:	Porcelain Powder
Classification Name:	Porcelain Powder for Clinical Use
Product Code:	EIH
Review Panel:	Dental
Regulation Number:	872.6660

Substantially Equivalent Predicate Legally Marketed Devices

The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.

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Device Name	Dentsply-CerconBase	3M-LAVA Zirconia	SagemaxBioceramics-Sagemax Z-Blank
510(k) Number	K013230	K011394	K062695
Decision Date	10/25/2001	06/29/2001	10/20/2006
Decision	SubstantiallyEquivalent	SubstantiallyEquivalent	SubstantiallyEquivalent
Product Code	EIH	EIH	EIH
Regulation Number	872.6660	872.6660	872.6660

Device Description

Indications for Use

The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Technological Characteristics and Substantial Equivalence

ZIROX and predicate devices are identical in intended use and material. Therewith, ZIROX and predicate devices are biocompatible and have similar biomechanical strength and properties.

Based on the discussion above, ZENCERA, INC. believes that ZIROX is substantially equivalent in comparison with predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized emblem, which includes an abstract representation of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. Sanho Hyun Assistant Manager Zencera, Incorporated Ace Techno Tower 5th, Room 1108 197-22 Guro-3Dong, Guro-Gu Seoul 152766 REPUBLIC OF KOREA

OCT 22 2009

Re: K092630

Trade/Device Name: ZIROX Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use 7Regulatory Class: II Product Code: EIH Dated: August 13, 2009 Received: August 27, 2009

Dear Mr. Hyun:

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 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. Hyun

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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

for

Susan Runner, D.D.S., M.A. Acting 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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Indications for Use

K092630

510(k) Number (if known): Device Name: ZIROX Indications for Use:

The ZIROX is intended for CAD/CAM fabrication of all-ceramic dental restorations. The ZIROX is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Kein Hurley for WSR

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

510(k) Number: K 092630

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.