NOBELRONDO DENTAL CERAMIC - ZIRCONIA

K043312 · Nobel Biocare USA, LLC · EIH · Feb 1, 2005 · Dental

Device Facts

• Record ID: K043312
• Device Name: NOBELRONDO DENTAL CERAMIC - ZIRCONIA
• Applicant: Nobel Biocare USA, LLC
• Product Code: EIH · Dental
• Decision Date: Feb 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.

Device Story

NobelRondo Dental Ceramic – Zirconia is a dental porcelain system used by dental technicians to veneer zirconia-based substructures (crowns, frameworks, abutments). The system includes 16 porcelain shades, shade modifiers for translucency/opalescence, mixing liquids, and shade guides. Technicians apply the porcelain in layers via a build-up process, followed by firing in a dental furnace. The final restoration provides aesthetic, natural-looking results for patients requiring dental prosthetics. The device is supplied in kit form with polyethylene bottles.

Clinical Evidence

Bench testing only. The device conforms to ISO 6872:1995 (Dental Ceramic), ISO 7405:1997 (Biocompatibility), and ISO 9693:1999 (Metal-ceramic Dental Restorative Systems).

Technological Characteristics

Dental porcelain powder. Materials conform to ISO 6872, ISO 7405, and ISO 9693. Form factor: powder kit with mixing liquids in polyethylene bottles. Processing: manual build-up and firing. No software or electronic components.

Indications for Use

Indicated for veneering zirconia substructures, including single crowns, multiple frameworks, or abutments.

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

• NobelRondo Dental Ceramic - Alumina (K041312)

Submission Summary (Full Text)

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FEB - 1 2005

Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The characters are 'K043312'. The characters are written in a bold, sans-serif font.

#### 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Elizabeth J. Mason<br>Sr. Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | November 30, 2004 |
| Classification Name: | Porcelain Powder for Clinical Use (21 CFR 872.6660) |
| Trade or Proprietary<br>or Model Name: | NobelRondo Dental Ceramic - Zirconia |
| Legally Marketed Device(s): | NobelRondo Dental Ceramic - Alumina (K041312) |

## Device Description:

NobelRondo Dental Ceramic – Zirconia is dental porcelain intended for use in the construction of zirconium oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides.

The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added.

The NobelRondo Dental Ceramic – Zirconia is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.

## Indications for Use:

NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.

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### Performance Standards 1.5

NobelRondo Dental Ceramic – Zirconia conforms with the following standards:

ISO 6872:1995 – Dental Ceramic

ISO 6872.1995 – Deltial Ceranic
ISO 7405:1997 – Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry – Test Methods for Dental Materials

ISO 9693:1999 – Metal-ceramic Dental Restorative Systems

These standards correspond to recognized consensus standards established under section 514 These Standards offeopond to Cosmetic Act for dental porcelain powder.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white circular seal. The seal contains the symbol of the Department of Health & Human Services, which is an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

FEB - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K043312

Trade/Device Name: NobelRondo Dental Ceramic - Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 30, 2004 Received: December 1, 2004

Dear Ms. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed younded the device is substantially equivalent (for the relereced above and have assessment to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merslate comments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to act research Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the sistration, 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 (1 WA), it may of basyed in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Mason

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 vour 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Chiu Lin, Ph.D.

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

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# Indications for Use

510(k) Number (if known): KDப் 331 Z

Device Name: NobelRondo Dental Ceramic - Zirconia

Indications For Use:

NobelRondo Dental Ceramic Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.

× Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Roase

് Division Sign-Off) Obleion of Anesthesiology, General Hospital, Intection Control. Dental Devices

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710(k) Number: C(0433)a

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