(63 days)
Not Found
Not Found
No
The summary describes a dental casting alloy, which is a material, not a software-based device, and there are no mentions of AI or ML.
No
The device is a dental casting alloy used for fabricating restorations, not for directly treating a disease or condition in a therapeutic manner.
No
The device is described as a "Non-Precious Dental Casting Alloy" for fabricating dental restorations, which indicates it is a material used in the creation of a medical device, not a device that performs diagnosis.
No
The device is described as a "Non-Precious Dental Casting Alloy," which is a material used in the fabrication of dental restorations. This 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 is for fabricating dental restorations, which are devices used in the mouth for structural purposes. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use clearly points away from diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical elements associated with IVDs.
Therefore, this device, a Non-Precious Dental Casting Alloy, 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
Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.
Product codes
EJH
Device Description
Not Found
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 (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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three wavy lines extending from its body, representing care and support.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Dr. Paul C. Chang President Mountain Medico, Incorporated 600 North Mountain Avenue, #D204 Upland, California 91786
Re: K030416
Trade/Device Name: Ceracast-V Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Codes: EJH Dated: February 05, 2003 Received: February 10, 2003
Dear Dr. Chang:
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 vour 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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Page 2 - Dr. Paul C. Chang
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. 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) you may obtain. 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 yours,
Susan Moore
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known): KO30416
Device Name: Ceracast-V
Indicalions For Use:
Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA NEEDED)
Concurrence of CDRH, Olfice of Device Evaluation (ODE)
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ------------------------ |
OR
| Division Sign-Off | Kerry MSR |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices |
| Over-The-Counter Use | (Optional Forma |
|---|---|
| ---------------------- | ----------------- |
| 510(k) Number: | K030416 |
|---|---|
| ---------------- | --------- |