(28 days)
K02904
No
The device description and intended use clearly describe a pressable ceramic material used for fabricating dental restorations. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance studies focus on material properties and equivalence to a predicate ceramic material.
No
The device is a dental ceramic material used for fabricating restorations, not a therapeutic device designed to treat a medical condition or ailment.
No
The device is a pressable ceramic material used by dental technicians to fabricate dental restorations, not to diagnose medical conditions or diseases.
No
The device is a pressable ceramic material, which is a physical substance used to fabricate dental restorations. It is 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 for constructing dental restorations (veneers, onlays, inlays, crowns). This is a structural and restorative application, not a diagnostic one.
- Device Description: The device is a pressable ceramic material used by dental technicians to fabricate these restorations. This describes a material used in a manufacturing process for a medical device, not a test performed on a biological sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 dental porcelains such as Willi Geller Creation & LF (K02904).
Product codes
EIH, ELL
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Match Press pressable ceramic: 510(k) number K024250
Reference Device(s)
K02904
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
K643221
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 |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 3, 2004 |
| Device Name:
Common Name:
Classification:
Product Code: | Willi Geller Creation CP Porcelain
Dental Porcelain
Class II
EIH |
| 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.
1
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.
2
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
3
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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