(48 days)
Not Found
No
The summary describes a ceramic material and its intended use in dental restorations, with no mention of AI or ML technology.
No
The device is a ceramic material used by dental technicians to construct dental prosthetics, which are restorative rather than therapeutic in nature. Its function is to replace or restore the form and function of teeth, not to treat a disease or medical condition.
No
The device is a pressable ceramic material used by dental technicians to construct dental prosthetics (veneers, inlays, crowns) and does not perform any diagnostic function.
No
The device is a physical ceramic material (porcelain pellets) used to fabricate dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to construct dental restorations (veneers, inlays, crowns, bridges) by dental technicians. This is a manufacturing process for a medical device that will be placed in the patient's mouth.
- Device Description: The device is a ceramic material used to fabricate dental prosthetics.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease or condition, or to examine specimens derived from the human body.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a material used in the creation of a medical device, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.
Product codes
ETH, EIH
Device Description
Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays. Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Creation CP-ZI substantially equivalent to the predicate devices Willi Geller Creation CP and Willi Geller Creation ZI porcelains The safety and effectiveness of Creation CP-ZI, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.
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
dental technicians
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)
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
Section E
510(k) SUMMARY
Submitted by:
Jensen Industries 50 Stillman Road North Haven CT 06473 · (203) 239-2090 phone (203) 234-7630 fax Contact: Gary Phelps
MAR O 1 2007
January 4, 2007 Date Prepared:
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Device Name: Common Name: Classification: Product Code:
Creation CP-ZI Porcelain Dental Porcelain Class II ETH
Predicate Devices
Willi Geller Creation CP: 510(k) number K043221 Willi Geller Creation ZI: 510(k) number K043201
Device Description
Creation CP-ZI porcelain consists of pressable ceramic pellets that are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and bridges. Creation CP-ZI is also suitable a s a stand-alone press ceramic for fabricating inlays and onlays. Data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Creation CP-ZI substantially equivalent to the predicate devices Willi Geller Creation CP and Willi Geller Creation ZI porcelains The safety and effectiveness of Creation CP-ZI, being determined by the shared chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473
MAR 3 1 2007
Re: K070114
Trade/Device Name: Creation CP-ZI Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 04, 2007 Received: January 19, 2007
Dear Mr. Phelps:
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.
2
Page 2 - Mr. Gary Phelps
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 your 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chin S. Lin, 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
3
Indications for Use
510(k) Number (if known): K670114
Device Name: Creation CP-ZI Porcelain
Indications for Use: Creation CP-ZI Porcelain is a pressable ceramic material intended to be used by dental technicians to construct veneers, inlays and ceramic crowns. CP-ZI can be pressed to zirconium oxide ceramic substructures for construction of ceramic crowns and bridges.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
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)
Super Kumar
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{DCF 3896}