(48 days)
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No
The summary describes a dental ceramic compound and its intended use in traditional dental restoration techniques. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
This device is a dental ceramic compound used for restorations; it does not mention treating or preventing a disease or condition.
No
The text describes HeraCeram Press as a dental ceramic compound used for veneering and restorations like veneers, inlays, onlays, and crowns. This indicates it is a material for treatment or repair, not a device used to diagnose a medical condition.
No
The device is a dental ceramic compound, 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 HeraCeram Press dental ceramic compound is for creating dental restorations (veneers, inlays, onlays, crowns). This is a material used in the mouth for structural purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique. Applications: Veneers, Inlays, Onlays and Crowns.
Product codes
EIII
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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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
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Image /page/0/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with its wings spread, symbolizing strength and national pride. The eagle is depicted in a simple, abstract manner, with flowing lines suggesting movement and freedom.
MAY 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl V. Zimmerman Director, Quality Operation & Regulatory Affairs Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re: K040859
Trade/Device Namc: HeraCeram Press Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codc: EIII Dated: March 24, 2004 Received: April 23, 2004
Dear Ms. Zimmerman:
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. Fxisting 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.
1
Page 2 – Ms. Zimmerman
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 (301) 594-4613. 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 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
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Indications for Use
510(k) Number (if known): __ K040859__________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:
HeraCeram Press dental ceramic compound is intended for use with the veneering ceramic material HeraCeram. It can be used for full ceramic restorations with the common layering technique as well as the staining technique.
Applications: Veneers, Inlays, Onlays and Crowns.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| Page | 1 of 1 |
|---|---|
| 510(k) Number: | K04059 |