(58 days)
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No
The summary describes a dental alloy for fabrication, with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
No
The device, Bioloy alloy, is used for the fabrication of dental devices, not for diagnosing, treating, or preventing disease.
No
The intended use describes the fabrication of custom-made dental devices, which is a manufacturing process, not a diagnostic one.
No
The summary describes a dental alloy used for fabricating dental devices, 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 is for the fabrication of custom-made dental devices like onlays, crowns, veneers, inlays, and PFM restorations. This is a manufacturing process for medical devices that are placed in or on the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of Bioloy alloy does not mention any diagnostic function or testing of biological samples. It's a material used to create dental prosthetics.
Therefore, Bioloy alloy falls under the category of a dental material used in the fabrication of medical devices, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bioloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays and PFM restorations.
Product codes
EJH
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
dentists and dental laboratories
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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§ 872.3710 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Neirynck & Vogt NV C/O Mr. Josh Andrachek Vacalon Company, Incorporated 12960 Stonecreek Drive, Suite C Pickerington, Ohio 43147
Re: K023477
Trade/Device Name: Bioloy Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: September 23, 2002 Received: October 16, 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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Page 2 - Mr. Josh Andrachek
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). 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,
Timothy A. Ulatowski
Timbthy 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
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510(k) Number (if known): KO23477
Device Name: Bioloy
.
Indications for Use:
Bioloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as onlays, ¼ crowns, veneers, inlays and PFM restorations.
(Please do not write below this line- Continue on another page if needed)
Prescription Use V (Per 21 CFR 801-109)
OR
Over-the-counter Use
(optional; format 1-2-96)
Susan Runne
(Division Sign=Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number .