(62 days)
NobelRondo Dental Ceramic - Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.
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.
The provided text describes a 510(k) submission for a dental ceramic product, NobelRondo Dental Ceramic – Zirconia. It outlines the device description, indications for use, and a list of performance standards to which it conforms. However, it does not contain information about a specific study designed to prove the device meets acceptance criteria, nor does it provide detailed device performance metrics in the way typically expected for clinical or performance studies.
The document primarily focuses on regulatory compliance through adherence to recognized consensus standards for dental ceramics and biocompatibility.
Therefore, many of the requested items cannot be extracted from this text.
Here's an attempt to populate the table and answer the questions based only on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Conformity to Standards | ISO 6872:1995 – Dental Ceramic | Device "conforms with" ISO 6872:1995 |
| ISO 7405:1997 – Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry – Test Methods for Dental Materials | Device "conforms with" ISO 7405:1997 | |
| ISO 9693:1999 – Metal-ceramic Dental Restorative Systems | Device "conforms with" ISO 9693:1999 | |
| Regulatory Status | Substantially Equivalent to Predicate Device | FDA reviewer determined the device is "substantially equivalent" to a legally marketed predicate (K041312) |
Note: The text explicitly states "NobelRondo Dental Ceramic – Zirconia conforms with the following standards". It does not report specific numerical performance data against these standards, but rather claims conformity.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text refers to conformity with standards but does not detail any specific test sets or studies that were conducted to demonstrate this conformity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device is a dental ceramic, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a dental ceramic, so this type of study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. The "ground truth" here is implied to be adherence to the specifications and performance requirements outlined in the cited ISO standards, likely demonstrated through material testing, but the details of such testing are not included.
8. The sample size for the training set
This information is not provided in the document. The device is a physical material, not a machine learning model, so the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
This information is not provided in the document (and is not applicable for this type of device).
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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. MasonSr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | November 30, 2004 |
| Classification Name: | Porcelain Powder for Clinical Use (21 CFR 872.6660) |
| Trade or Proprietaryor 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of 1
710(k) Number: C(0433)a
1.3
§ 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.