(43 days)
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No reference devices are mentioned in the provided text.
No
The summary describes a dental alloy for fabricating dentures and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
A removable partial denture, which is fabricated from Chroloy alloy, is a custom dental device used to replace missing teeth. It functions as a prosthetic device and facilitates chewing and speaking, but it does not directly treat or cure a disease or condition. Therefore, it is not considered a therapeutic device.
No
The device is described as an alloy for fabricating dental devices like removable partial dentures, which are therapeutic or restorative, not diagnostic. Its intended use is fabrication, not detection, diagnosis, or monitoring of a disease or condition.
No
The 510(k) summary describes a dental alloy, which is a material used in the fabrication of dental devices. 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 the fabrication of custom-made dental devices like removable partial dentures. This is a manufacturing process for a medical device that is placed in the body, not a test performed on a sample taken from the body to diagnose a 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.)
- Providing diagnostic information
- Using reagents or assays
The device is a material (alloy) used to create a dental prosthesis. This falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Chroloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as removable partial dentures.
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
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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Neirynck & Vogt NV C/O Mr. Josh Andrachek Vacalon Company, Incorporated 12960 Stonecreek Drive Pickerington, Ohio 43147
Re: K021969
Trade/Device Name: Chroloy 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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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 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 yours,
Victor A
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): K021969
Device Name: Chroloy
Indications for Use:
Chroloy alloy is intended to be used by dentists and dental laboratories for the fabrication of custom made dental devices such as removable partial dentures.
(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)
Susan Rurser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________