(27 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device is used to create a prosthesis, which is a replacement for a missing body part, not to treat a disease or condition. Prosthetic dentistry focuses on the fabrication and fitting of artificial devices, rather than therapeutic intervention.
No
The "Intended Use / Indications for Use" states "For use in prosthetic dentistry to create an all-ceramic prosthesis," which indicates a manufacturing or design function, not a diagnostic one.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use suggests a physical prosthesis is created, which would involve hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in prosthetic dentistry to create an all-ceramic prosthesis." This describes a device used in the mouth or on dental models to fabricate a physical dental restoration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to perform tests on biological samples to gain diagnostic or other health-related information. This device's purpose is purely related to the fabrication of a dental prosthesis.
N/A
Intended Use / Indications for Use
For use in prosthetic dentistry to create an all-ceramic prosthesis
Product codes
EIH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
JAN 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007
Re: K043462
Trade/Device Name: CZR Press LF Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2004 Received: December 15, 2004
Dear Mr Wasserman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) pic.harter is substantially equivalent (for the indications for referenced above and have delemined the ace rices marketed in interstate commerce
use stated in the enclosure) to legally market devices marketed in interstate use stated in the enclosure) to legally filanced produce Amendments, or to devices that prior to May 28, 1976, the enacthen with the provisions of the Federal Frod, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From W have been reclassified in accordance with the provisions of the Act. The mays.
Act (Act) that do not require approval of a premarket approval applications of the general Act (Act) that do not require apploval of a prematice applo realizions of the Act. The general
therefore, market the device, subject to the general controls provisions of de therefore, market the device, subject to the senents for annon registration, listing of devices, good
controls provisions of the Act include requirements for annial registeri controls provisions of the Act mender requirements are at adulteration.
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 If your device is classified (see above) into Club Class in (erest ons affecting your device can be
may be subject to such additional controls. Existing major regulations F may be subject to such additions, Title 21, Parts 800 to 89%. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 89%. In additio found in the Code of Federal reegalament, your device in the Federal Register.
1
Page 2 - Mr. Ivan J. Wasserman, Esq.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a solenice complies with other requirements of the Act or that FDA made a decemination max your ced by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); all the Act s requirements, monacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good management of any from 11 case on one product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product Systems (QD) 105-105-131-542 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 his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothleation: "The FDA midning of backanse of 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), please If you desire specific advice ion your ac now to 2011-01-11 5. Also, please note the regulation entitled, comact the Office of Comphance at (210) 27 of CFR Part 807.97). You may obtain other Misoraliums of reference to promaibilities under the Act from the Division of Small general intornation on your responsionnes 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,
Carl S. Luip, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
1043462 510(k) Number (if known):
Device Name: CZR Press LF
Indications For Use:
For use in prosthetic dentistry to create an all-ceramic prosthesis
Prescription Use
(Part 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Syoom Russe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of _ |
Kouzyler 510(k) Number:_
7