(54 days)
Not Found
No
The 510(k) summary describes a dental ceramic material and its intended use in fabricating dental restorations. There is no mention of AI, ML, image processing, or any other technology that would suggest the incorporation of AI/ML. The performance studies focus on material properties and equivalence to predicate devices.
No
The device is a dental ceramic material used by dental technicians to fabricate dental restorations, which is a structural component and not a therapeutic agent.
No
The device is a ceramic material used for dental restorations (veneering zirconium oxide), which is a restorative rather than a diagnostic function.
No
The device is a ceramic material, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "form dental restorations" by veneering zirconium oxide cores. This is a process performed outside the body to create a physical dental device.
- Device Description: It describes a "dental ceramic" used by "dental technicians to fabricate dental restorations." This reinforces its use in a laboratory or dental practice setting for creating a physical product.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
Therefore, Willi Geller Creation ZI Porcelain is a dental material used in the fabrication of dental restorations, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations
Product codes
EIH
Device Description
Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation ZI substantially equivalent to the predicate device Willi Geller Creation& AV Porcelain. The safety and effectiveness of Willi Geller Creation ZI , being determined by the 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
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)
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
JAN, 11, 2005
Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries
50 Stillman Road
North Haven CT 06473
(203) 239-2090 phone
(203) 234-7176 fax
Contact: Gary Phelps |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 1, 2004 |
| Device Name:
Common Name:
Classification:
Product Code: | Willi Geller Creation ZI Porcelain
Dental Porcelain
Class II
EIH |
| Predicate Devices: | Willi Geller Creation& AV Porcelain: 510(k) number K002041
Lava Ceram: 510(k) number K011394* |
Device Description
Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation ZI substantially equivalent to the predicate device Willi Geller Creation& AV Porcelain. The safety and effectiveness of Willi Geller Creation ZI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.
- see page 10
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name in a ring around the outside. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2005
Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K043201
Trade/Device Name: Willi Geller Creation ZI Porcelain Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: October 12, 2004 Received: November 18, 2004
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. 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 modifine in or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal backed as a requirements, including, but not limited to: registration Tournust comply with an are reveling (21 CFR Part 801); good manufacturing practice alle listing (21 CFR Part 807), and lite 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) This letter wiff anon yourse Finding of substantial equivalence of your device to a premits clothed.com - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), if you desire specific at Compliance at (301) 594-0115. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entition, "Therefinance al information on your responsibilities under the Act from the may obtain 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,
Owe
Tillman, Liu, 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
3
Indications for Use
510(k) Number (if known): K043201
Device Name: Willi Geller Creation ZI Porcelain
Indications for Use: Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K04320
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