(67 days)
NobelRondo Dental Ceramic Alumina is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from alumina.
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.
This document is a 510(k) Summary of Safety and Effectiveness for the NobelRondo Dental Ceramic – Alumina, a dental porcelain. It does not present any data relating to artificial intelligence (AI) or machine learning (ML) device performance.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device that uses AI.
The document discusses the physical properties and intended use of a dental ceramic material and its substantial equivalence to a legally marketed predicate device (Procera® All-Ceramic Dental Porcelain). The FDA's review in this case is focused on the material's safety and effectiveness for its stated dental applications, not on the performance of a diagnostic or assistive AI system.
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510(k) Summary of Safety and Effectiveness 1.4
长641312
| Submitted by: | Elizabeth J. MasonSr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | May 14, 2004 |
| Classification Name: | Porcelain Powder for Clinical Use (21 CFR 872.6660) |
| Trade or Proprietaryor 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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:
§ 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.