NOBELRONDO DENTAL CERAMIC-ALUMINA

K041312 · Nobel Biocare Uas, Inc. · EIH · Jul 23, 2004 · Dental

Device Facts

• Record ID: K041312
• Device Name: NOBELRONDO DENTAL CERAMIC-ALUMINA
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: EIH · Dental
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

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

Device Story

NobelRondo Dental Ceramic – Alumina is a dental porcelain system used by dental technicians to construct aluminum oxide ceramic prosthetics. The system includes sixteen porcelain shades (Vita A0-C3), shade modifiers, mixing liquids, and shade guides. Technicians apply the porcelain in a build-up process, typically involving a base liner, build-up material, and final glazes/stains, followed by firing. Modifiers allow for translucent or opalescent effects. The device is supplied in kit form with polyethylene bottles. The final prosthetic is used by dentists to restore patient dentition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental porcelain powder for clinical use. Materials: Alumina-based ceramic components. Form factor: Powder/liquid kit in polyethylene bottles. Processing: Manual build-up and firing. No software or electronic components.

Indications for Use

Indicated for veneering alumina-based dental 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

• Procera® All-Ceramic Dental Porcelain (K944702)

Submission Summary (Full Text)

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

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| Submitted by: | Elizabeth J. Mason<br>Sr. Regulatory Affairs Specialist |
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| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | May 14, 2004 |
| Classification Name: | Porcelain Powder for Clinical Use (21 CFR 872.6660) |
| Trade or Proprietary<br>or Model Name: | NobelRondo Dental Ceramic - Alumina |
| Legally Marketed Device(s): | Procera® All-Ceramic Dental Porcelain (K944702) |

## Device Description:

NobelRondo Dental Ceramic – Alumina is dental porcelain intended for use in the construction of aluminum 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 – Alumina 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 Alumina is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from alumina.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041312

Trade/Device Name: NobelRondo Dental Ceramic-Alumina Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 14, 2004 Received: May 17, 2004

Dear Ms. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rowary bave 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 mendments, 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 approvisions 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 (1 Nr.), it hay of bund 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 - 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 mean that I Dr mas and statutes and regulations administered by other Federal agencies. or the rice of any - each all the Act's requirements, including, but not limited to: registration r od intil 1 compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (2) 21 result 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) I mis letter will and in J . The FDA finding of substantial equivalence of your device to a premiures notificated 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), n you desire the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entified, "Miscraft" and information on your responsibilities under the Act from the maj Sound Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suan Runne

Shiu-Ling Chiu, 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):

Device Name: NobelRondo Dental Ceramic - Alumina

Indications For Use:

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

× 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 Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital, Page 1 of _1_ ______________________________________________________________________________________________________________________________________________________________________________ Infection Control, Dental Devices

510(k) Number: