ZMATCH BLOCK

K083201 · Dentaim Co., Ltd. · EIH · Jan 26, 2009 · Dental

Device Facts

• Record ID: K083201
• Device Name: ZMATCH BLOCK
• Applicant: Dentaim Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Jan 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Indications for Use

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

Device Story

Zmatch® Block is a pre-formed, machineable zirconium oxide ceramic blank; available in partially-sintered state; offered in two material composition models (A-type and B-type). Used by dental laboratories or clinicians with CAD/CAM milling equipment to fabricate dental restorations (inlays, onlays, veneers, crowns, bridges). Device serves as raw material for milling; final restoration is placed by dental professionals. Benefits include patient-specific, high-strength ceramic restorations.

Clinical Evidence

No clinical data; substantial equivalence based on material and technological characteristics.

Technological Characteristics

Pre-formed machineable ceramic blank composed of zirconium oxide. Available in partially-sintered form. Two models (A-type and B-type) with varying material compositions. Designed for CAD/CAM milling.

Indications for Use

Indicated for patients requiring all-ceramic dental restorations, including inlays, onlays, veneers, crowns, and bridges, fabricated via CAD/CAM processes.

Regulatory Classification

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.

Predicate Devices

• Sagemax Z-Blank (K062695)
• Dentsply-Cercon Base (K013230)
• 3M-LAVA Zirconia (K11394)

Submission Summary (Full Text)

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# JAN 2 6 2009

# 510(k) SUMMARY

#### Submitter

| Name | Dentaim Co ,Ltd |
|---------|--------------------------------------------------------------------------------|
| Address | Room No 401, ACE techno Tower 1st, 197-17, Guro-Dong,<br>Guro-Gu, Seoul, Korea |

### US Agent:

| Name | Won Chul Lee |
|----------|-----------------------------------------------|
| Address | 1352 Amberlea Dr E , Gahanna Ohio 43230 U S A |
| Phone No | 614-444-0660 |
| E-Mail | [e-mail] |

### Official Correspondent:

| Name | Daesuck Chun |
|----------|--------------------------------------------------------------------------------|
| Address | Room No 401, ACE techno Tower 1st, 197-17, Guro-Dong,<br>Guro-Gu, Seoul, Korea |
| Phone No | [phone] |
| Fax No | [phone] |
| E-Mail | [e-mail] |

## Device Identification

1

| Proprietary Name | Zmatch® Block |
|---------------------|-----------------------------------|
| 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

| Device Name | Sagemax<br>Bioceramics-<br>Sagemax Z-Blank | Dentsply-Cercon<br>Base | 3M-LAVA<br>Zirconia |
|---------------|--------------------------------------------|-------------------------|---------------------|
| 510(k) Number | K062695 | K013230 | K11394 |

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| אין אין<br>/ | |
|-----------------------|--|
| /<br>-<br>1<br>1<br>1 | |

| Decision Date | 10/20/2006 | 10/25/2001 | 06/29/2001 |
|-------------------|-----------------------------|-----------------------------|-----------------------------|
| Decision | Substantially<br>Equivalent | Substantially<br>Equivalent | Substantially<br>Equivalent |
| Product Code | EIH | EIH | EIH |
| Regulation Number | 872 6660 | 872 6660 | 872 6660 |

#### Device Description

Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition

Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block 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

#### Indications for Use

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

#### Technological Characteristics and Substantial Equivalence

Zmatch® block and predicate devices are identical in intended use and material Therewith, Zmatch® block and predicate devices are biocompatible and have similar biomechanical strength and properties

Based on the discussion above, Dentaim Co ,Ltd believes that Zmatch® block is substantially equivalent in comparison with predicate devices

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr Daesuck Chun Manager Dentam Company, Lımıted Room No 401, ACE Techno Tower 1st 197-17, Guro-Dong, Guro-Gu Seoul, Korea

JAN 2 6 2009

Re K083201

Trade/Device Name Zmatch® Block Regulation Number 872 6660 Regulation Name Porcelain Powder for Clinical Use Regulatory Class II Product Code EIH Dated October 28, 2008 Received October 30, 2008

Dear Mr Chun

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 ındıcations 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 affectung 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 Chun

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 [phone] 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 [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry/support/index html

Sincerely yours.

Anthony D a whom for
Ginette Y Michaud, M D

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

K083201 510(k) Number (if known): Zmatch® Block Device Name: Indications for Use:

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

Prescription Use _ V (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)

Suce-Rurnes

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

510(k) Number: K083201