(28 days)
Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing porcelains such as Willi Geller Creation GC or Willi Geller Creation LF (K02904).
Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains.
This document, K043221, is a 510(k) Pre-market Notification for a dental porcelain product called "Willi Geller Creation CP Porcelain." As such, it does not contain the kind of study information you are asking for, which is typical for diagnostic medical devices or those with more complex performance claims. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use, rather than clinical performance metrics like sensitivity, specificity, or reader studies.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The document states: "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation CP, being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices."
This implies that the "study" for this device involved comparing its physical and chemical properties to those of the predicate device (Match Press pressable ceramic, K024250) to establish substantial equivalence. However, the details of these comparisons (e.g., specific tests, acceptance criteria, results) are not included in the provided 510(k) summary.
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K643221
Section E
510(k) SUMMARY
| Submitted by: | Jensen Industries50 Stillman RoadNorth Haven CT 06473(203) 239-2090 phone(203) 234-7630 faxContact: Gary Phelps |
|---|---|
| Date Prepared: | November 3, 2004 |
| Device Name:Common Name:Classification:Product Code: | Willi Geller Creation CP PorcelainDental PorcelainClass IIEIH |
| Predicate Device: | Match Press pressable ceramic: 510(k) number K024250 |
Device Description
Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation Ch , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.
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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2004
Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K043221
Trade/Device Names: Willi Geller Creation CP Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH and ELL Dated: October 16, 2004 Received: November 22, 2004
Dear Mr. Phelps:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaused in " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass batted in also energent date of the Medical Device Amendments, or to devices that proof to they 20, 1978, are cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been toetablication in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, marker 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 may of subject to been all 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. Gary Phelps
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I D7T s issualled on and other complies with other requirements of the Act or that FDA nas made a decemination and Joistered by other Federal agencies. You must comply with CEP Poss Box 2007 all rederal statutes and regulations animalians in the registration and listing (21 CFR Part 807); all the Act s requirements, merading, out increasing practice requirements as set forth in the quality labeling (21 CFR Part 001), good management of the electronic product radiation systems (QB) rogs (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 witi anow you to ogin marketing of substantial equivalence of your device to a legally premits touriedition: "The PDF maning of vation 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 If you desire specific at (240) 276-0115. Also, please note the regulation entitled, contact the Office of Comphance as (210) = 6 otion't (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities 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 Kuanen
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
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Indications for Use
510(k) Number (if known): K043221
Device Name: Willi Geller Creation CP Porcelain Indications for Use:
Willi Geller Creation CP Porcelain is a pressable ceramic material intended for Willi Geller Creation CP Porcelant is a preodable ventures and full contour restorations.
constructing veneer, onlay, inlay, and crown substructures and fusing constructing veneer, only, and Grown of the suitable conventional or low fusings
Veneering of substructures can be performed with suitable convention & I Veneering of substructures can be performed with Galabo or Willi Geller Creation & LF (K02904).
× Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suse Rower
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K413221
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§ 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.