(33 days)
Not Found
No
The 510(k) summary describes a ceramic material system for dental restorations and substructures. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on material properties and equivalence to predicate devices, not algorithmic performance.
No
This device is a ceramic material used for dental restorations, which is a structural/restorative purpose, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device is a ceramic material used for dental restorations, not for diagnosing conditions.
No
The device is described as a ceramic material formed into pellets, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LF-P Ceramic System is a material for creating dental restorations (crowns, onlays, inlays, veneers, and substructures). This is a material used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces that it's a ceramic material for dental restorations.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This ceramic system does not fit that description.
N/A
Intended Use / Indications for Use
the LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
Product codes
EIH
Device Description
The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make the LF-P Ceramic System substantially equivalent to the predicate devices Ceramco Finesse All Ceramic and Willi Geller Creation & LF. The safety and effectiveness of the LF-P Ceramic System, being determined by the chemical qualities, cytotoxicity test results 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
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Anatomical Site
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Indicated Patient Age Range
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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
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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
MAY - 4 2005
Section E
510(k) SUMMARY
Jensen Industries Submitted by: 50 Stillman Road North Haven CT 06473 (203) 239-2090 phone (203) 234-7630 fax Contact: Gary Phelps
Date Prepared: March 3, 2005 The LF-P Ceramic System Device Name: Dental Porcelain Common Name: Classification: Class II Product Code: EIH Predicate Devices:
Ceramco Finesse All Ceramic (K971869) Willi Geller Creation & LF (K002904)
Device Description
The LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make the LF-P Ceramic System substantially equivalent to the predicate devices Ceramco Finesse All Ceramic and Willi Geller Creation & LF. The safety and effectiveness of the LF-P Ceramic System, being determined by the chemical qualities, cytotoxicity test results and mechanical properties, is therefore equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the symbol of the Department of Health and Human Services (HHS) in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2005
Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473
Re: K050838
Trade/Device Name: The LF-P Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: March 30, 2005 Received: April 06, 2005
Dear Mr. Phelps:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your books on (1) }) }) }) } }) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enotoure) to regist 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 have been receitive in accordination of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, manker the device, babyev we an emirements for annual registration, listing of devices, good controlly provisions of the 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 If your device to such additional controls. Existing major regulations affecting your device can be may of subject to ston additions, 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 that 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 laboring (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) rms letet notification. The FDA finding of substantial equivalence of your device to a legally prematics notification - 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 if you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general informational 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/industry/support/index.html.
Sincerely yours,
Owes
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
Enclosures
3
Indications for Use
510(k) Number (if known):
Device Name: The LF-P Ceramic System
Indications for Use: the LF-P Ceramic System is a ceramic material formed into pellets Indications for Use: the Lr-F Cerumic Systems onlays, inlays and veners) and intended for pressing into till conventional precious and non-precious metal substructures.
substructures as well as pressing to conventional precious artin's laze finishing. substructures as well as pressing to conventional precious and not p
The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.
AND/OR Prescription Use 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)
Kein Mulvey for NSR
Sign-Off) I ivision of Anesthesiology, General Hospital, Intection Control, Dental Devices
:(k) Number. K050838
Page 1 of
(Ref: DCF 3419)