(39 days)
Not Found
Not Found
No
The 510(k) summary describes a dental solder, a material used in dental restorations. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
This device is a dental solder used in the fabrication and repair of dental restorations, not for treating any specific disease or condition.
No
The device, Ceraloy Solder, is used for the repair and fabrication of dental restorations (crowns, veneers, bridges, etc.). This is a therapeutic or restorative function, not a diagnostic one. It does not identify or diagnose a disease or condition.
No
The device is a solder, which is a physical material used in dental procedures, not a software application.
Based on the provided information, Ceraloy Solder is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use by dentists and dental laboratories in the repair and fabrication of dental restorations. This is a direct application on a patient or for creating devices that will be used on a patient, not for testing samples in vitro (outside the body).
- Device Description: While "Not Found," the intended use provides enough context to understand its function.
- No mention of biological samples: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue). The description of Ceraloy Solder's use does not involve any such samples.
- No mention of diagnostic purposes: The purpose is fabrication and repair, not diagnosing a condition or providing information about a patient's health status.
Therefore, Ceraloy Solder falls under the category of a dental device used in the creation and repair of dental prosthetics, not an IVD.
N/A
Intended Use / Indications for Use
Ceraloy Solder is intended to be used by dentists and dental laboratories as a solder for Ceraloy alloy. It is used in the repair and fabrication of crowns, veneers, onlays, 34 crowns, short and long span bridgework and PFM restorations.
Product codes
EJH
Device Description
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
dentists and dental laboratories
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with a snake winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2002
Neirynck & Vogt NV C/O Mr. Josh Andrachek Vacalon Company, Incorporated 12960 Stonecreek Drive Pickerington, Ohio 43147
Re: K021968
Trade/Device Name: Ceraloy Solder Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: June 17, 2002 Received: June 17, 2002
Dear Mr. Andrachek:
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Patricia Ciccantelli for
Timothy A. Ulatowski 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
Page 1 of 1
510(k) Number (if known): K021968
Device Name: Ceraloy Solder
Indications for Use:
Ceraloy Solder is intended to be used by dentists and dental laboratories as a solder for Ceraloy alloy. It is used in the repair and fabrication of crowns, veneers, onlays, 34 crowns, short and long span bridgework and PFM restorations.
(Please do not write below this line- Continue on another page if needed)
Prescription Use (Per 21 CFR 801-109) OR
Over-the-counter Use
(optional; format 1-2-96)
AutsBetz mps for Dr Susan Runner.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number_ 0