(27 days)
K00290
Not Found
No
The summary describes a dental ceramic material and its mechanical/chemical properties, with no mention of software, algorithms, or AI/ML terms.
No.
The device is a ceramic material used for veneering dental restorations, which is a structural component rather than a device intended to treat or cure a disease or condition.
No
The device is a ceramic material used for veneering titanium alloy cores to form dental restorations. It is a material used for fabrication, not for diagnosis.
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 for "veneering of titanium alloy cores and substructures to form dental restorations." This describes a material used in the fabrication of a medical device (a dental restoration), not a test performed on a sample from the human body to provide diagnostic information.
- Device Description: The description focuses on the material properties (mechanical, chemical) and its use by dental technicians to fabricate restorations. It doesn't mention any diagnostic function or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a dental material used in the manufacturing process of a dental restoration.
N/A
Intended Use / Indications for Use
Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.
Product codes
EIH
Device Description
Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , 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
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)
K00290
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) 234-7176 fax
Contact: Gary Phelps |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 14, 2004 |
| Device Name:
Common Name:
Classification:
Product Code: | Willi Geller Creation TI Porcelain
Dental Porcelain
Class II
EIH |
| Predicate Devices: | Willi Geller Creation& LF Porcelain: 510(k) number K00290 |
Device Description
Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , 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 shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo features a staff with two snakes entwined around it, topped with a pair of wings.
JAN 1 2 2005
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
Re: K043468
Trade/Device Names: Willi Geller Creation TI Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2004 Received: December 16, 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. 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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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): K043468
Device Name: Willi Geller Creation TI Porcelain Indications for Use:
Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.
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)
Susan R
(Division Sign-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices
Page 1 of 1
510(k) Number ________________________________________________________________________________________________________________________________________________________________