(22 days)
Not Found
No
The 510(k) summary describes a dental ceramic veneering material and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a dental ceramic veneering material used in prosthodontics, which is a material used to build or restore a structure, rather than a device intended to directly treat or cure a disease or condition.
No
The device is described as a dental ceramic veneering material for fixed prosthodontics devices. It does not perform any diagnostic function; rather, it is a material for manufacturing restoration devices.
No
The device description clearly states it is a "dental ceramic veneering material" and lists physical components like "Dentin/Transparent/Incisal porcelain," "Liner/Opaque porcelain," etc. This indicates it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is designed for use on zirconia restorations in the mouth (anterior and posterior teeth). This is a dental material used for fabricating or repairing dental prosthetics.
- Device Description: The description details a dental ceramic veneering material consisting of different types of porcelain. This aligns with a material used in dental laboratories or clinics for creating dental restorations.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. The provided description does not mention any of these activities.
- Anatomical Site: The anatomical site is the mouth/teeth, which is where the dental restoration is placed, not where a specimen is collected for in vitro testing.
- Predicate Device: The predicate device (K022796 Cercon® Ceram S Porcelains) is also a dental porcelain material, further supporting that this device falls under the category of dental materials, not IVDs.
In summary, the PFZ™ PORCELAIN SYSTEM is a dental material used for creating dental restorations, not a device used for testing biological specimens outside the body.
N/A
Intended Use / Indications for Use
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
The PFZ™ PORCELAIN SYSTEM is a dental ceramic veneering DEVICE DESONIT TOT ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . for fixed prosthodontics devices that include both anterior and posterior crowns/bridges.
The PFZ™ PORCELAIN SYSTEM consists of a Dentin/Transparent/Incisal porcelain, a Liner/Opaque porcelain, a Shoulder porcelain, and a Correction/Glaze/Stain porcelain in tooth colored shades..
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)
All of the components have been used in legally marketed devices. PFZTM PORCELAIN was evaluated and passed biocompatibility testing for cytotoxicity.
We believe that the prior use of the components in legally markcted devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the PFZTM PORCELAIN SYSTEM for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cercon® Ceram S Porcelains K022796
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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DEC - 2 2003
CONTACT:
510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY International
P. J. Lehn Telefax (71
P. Jeffery Lehn
DATE PREPARED: November 7, 2003
TRADE NAME: PFZ™ PORCELAIN SYSTEM
Porcelain Powder for Clinical Use (872.6660) CLASSIFICATION NAME:
PREDICATE DEVICES: Cercon® Ceram S Porcelains K022796
DEVICE DESCRIPTION: The PFZ™ PORCELAIN SYSTEM is a dental ceramic veneering DEVICE DESONIT TOT ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . for fixed prosthodontics devices that include both anterior and posterior crowns/bridges.
The PFZ™ PORCELAIN SYSTEM consists of a Dentin/Transparent/Incisal porcelain, a Liner/Opaque porcelain, a Shoulder porcelain, and a Correction/Glaze/Stain porcelain in tooth colored shades..
The PFZ™ PORCELAIN SYSTEM is for use on zirconia (zirconium INTENDED USE: oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.
TECHNOLOGICAL CHARACTERISTICS: The PFZ™ PORCELAIN SYSTEM represents a TECITINGEOOTERE Cram S Porcelains (K022796). Minor changes have been made in the device's formulation.
All of the components have been used in legally marketed devices. PFZTM PORCELAIN was evaluated and passed biocompatibility testing for cytotoxicity.
We believe that the prior use of the components in legally markcted devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of the PFZTM PORCELAIN SYSTEM for the intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K033553
Trade/Device Name: PFZ™ Porcelain System Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 7, 2003 Reccived: November 10, 2003
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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 Amendments, 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 controls provisions 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 your device can be found 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 - Mr. Lehn
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 (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other gencral 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/dsma/dsmamain.html
Sincerely yours,
Susan Runne
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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33553
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name: PFZ™ PORCELAIN SYSTEM
Indications for Use:
Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.
Robert J. Shatz DDS for Dr. Susan Runner
General Hospital. 510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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