NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100

K091096 · Dental Solutions, Inc. · EIH · Jun 18, 2009 · Dental

Device Facts

• Record ID: K091096
• Device Name: NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
• Applicant: Dental Solutions, Inc.
• Product Code: EIH · Dental
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled: 'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals.'

Device Story

NaturaZ Series (B16, B20, B42, B60, B98, B100) consists of pre-formed porcelain powder materials. Used by dental laboratory professionals to manufacture dental prosthetics. Device serves as raw material for prosthetic fabrication. Clinical benefit derived from restoration of dental function and aesthetics via custom-manufactured prosthetics.

Clinical Evidence

No clinical data; bench testing not required based on equivalence to predicate.

Technological Characteristics

Pre-formed porcelain powder for dental prosthetic manufacture. Classified as porcelain powder for clinical use (21 CFR 872.6660).

Indications for Use

Indicated for use by dental laboratories in the manufacture of dental prosthetics. Restricted to sale to or on the order of licensed professionals.

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

• KaVo Everest® ZS-Blank (K032081)

Submission Summary (Full Text)

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K09/096

## 510(K) SUMMARY NaturaZ Series

JUN 18 2009

This 510(k) summary of safety and effectiveness for NaturaZ Series (B16, B20,
11 CFR This 510(k) summary of safety and ellectivel.ose for Natures in National Part 21 CFR
B42, B60, B98, B100) material is submitted in accordance under Part 21 CFR 807.92.

The Dental Solution, Inc. APPLICANT:

Geum Cheon Gu, Ga San Dong, 371-36 ADDRESS: 4th Floor S&T Building Seoul, Korea 153-803

MANUFACTURER: DMAX Co., LTD DMAX OS:, EFB
Geum Cheon Gu, Ga San Dong, 371-36 4th Floor S&T Building Seoul, Korea 153-803

CONTACT PERSON: Andrew Paeng, Consultant

[phone], FAX [phone] TELEPHONE:

naturaz series (B16, B20, B42, B60, B98, B100) DEVICE NAME:

COMMON NAME: Porcelain, Powder for clinical use

- CLASSIFICATION: Porcelain, Porcelain, Powder for clinical use 21 CFR 872.6660 Class II Product Code: EIH Panel: 76 (Dental)
PREDICATE DEVICE: KaVo Everest® ZS-Blank K032081

# DEVICE DESCRIPTION:

lON:
NaturaZ Series is a pre-formed material for use by dental labo-NaturaZ Senes is a pre-formou material prosthetics

- NaturaZ Series is used inthe manufacture of dental prosthetics. NaturaZ Series is used intrie manufacture of the materials distributed.
The Dental Solution, Inc. proposes that the materials distributed. INDICATION: The Dental Solation of States be labeled:
"CAUTION: Federal (US) law restricts the sale of this device to, "
"CAUTION: Federal (US) law restricts " CAOTION: Pedoral (onsed professionals."

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## 510(K) SUMMARY NaturaZ Series (B16, B20, B42, B60, B98, B100)

### (Page 2 of 2)

PERFORMANCE DATA: Non Required. The claim of substantial equivalence is
t the productions from the productions and intended uses of the predicate device, PERFORMANCE DATA: Non Required: The claim of ourselands of the predicate device,
based on comparisons of formulations and intended uses of the predicate device, KaVo Everest ZS-Blank.

CONCLUSION: There are no significant differences between the NaturaZ Series are equally safe and effective CONCLUSION: There are no significant uniterenoos betwoon in and effective
and the predicate device. Therefore, NatureZ Series are equally safe and effective
France and the and the predicate device, KaVo Everest ZS--Blank.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three wing-like shapes extending to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.

#### Public Health Service

JUN 18 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Dental Solution, Incorporated C/O Mr. Andrew Paeng Consultant The Dental Solution America, Incorporated 9301 Wilshire Boulevard PH5 Beverly Hills, California 90210

Re: K091096

Trade/Device Name: NaturaZ Series B16, B20, B42, B60, B98, B100 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: ETH Dated: April 15, 2009 Received: April 16, 2009

Dear Mr. Paeng:

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. Paeng

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

Sincerely vours.

Sheon Rumper

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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# INDICATION OF USE

510(k) Number:

DEVICE NAME: NaturaZ Series B16, B20, B42, B60, B98, B100

INDICATION FOR USE: NaturaZ Series is used in the manufacture of dental prosthetics. The Dental Solution, Inc. proposes that the materials distributed within the United States be labeled:

'CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."

Prescription Use (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)

Kei Wuley for MSE

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

510(k) Number: K091091