(41 days)
Austenal "Advantage", Jeneric "RX Biocast" CMP "Vulcan"
Not Found
No
The summary describes a traditional dental alloy and its intended use and performance, with no mention of AI or ML.
No.
The device is a cobalt-based alloy used for fabricating dental prostheses (crowns/bridges) in a dental laboratory, serving as an alternative material rather than directly treating a medical condition or ailment.
No
The device is a material (cobalt-based alloy) used for fabricating dental prostheses (crowns and bridges), not for diagnosing medical conditions. Its intended use is for fabrication, not for diagnosis.
No
The device description clearly states it is a "cobalt based crown and bridge alloy," indicating it 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 a custom crown or bridge prosthesis by a dental laboratory. This is a manufacturing process for a medical device (dental prosthesis), not a diagnostic test performed on a biological sample.
- Device Description: The device is a cobalt-based alloy used as a material for creating a prosthesis. It's a material, not a diagnostic reagent or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys.
Product codes
EJH
Device Description
P10 Special alloy is a cobalt based crown and bridge alloy containing chromium and molybdenum.
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
dental laboratory
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)
Performance testing by field laboratories indicated that P10 Special met or exceeded performance standards of traditional crown and bridge alloys being utilized.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Austenal "Advantage", Jeneric "RX Biocast" CMP "Vulcan"
Reference Device(s)
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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NOV 1 5 1999
H AMERICAN ALLOY
Image /page/0/Picture/3 description: The image shows a black and white drawing of an eagle perched on a branch. The eagle is facing to the right and has its wings spread. The eagle's feathers are detailed, and its beak is open. The branch is also detailed, and it has leaves on it. The background is white.
225 Brentwood Ct. • Bloomingdale, IL 60108-2111 • 630-980-5618
510(k) SUMMARY
Trade name: "P10 Special" Alloy Common name: Base Metal Alloy Classification name: Base Metal Alloy (per 21 CFR 872.3710)
P10 Special alloy is a cobalt based crown and bridge alloy containing chromium Device Description: and molybdenum.
Intended use: The fabrication of a custom crown or bridge prosthesis by a dental laboratory.
Predicate devices: Austenal "Advantage", Jeneric "RX Biocast" CMP "Vulcan" are Co-based crown and bridge alloys.
Summary of Technological Characteristics:
A comparison of compositional analysis indicates P10 Special and the predicate devices to be similar, with a total Co/Cr/Mo sum percentage of 89-94 %.
A comparison of physical properties indicates P10 Special alloy is similar in yield strength to "Advantage". "P10 Special" has a higher yield strength but is not as hard as Vulcan. Vulcan exhibited somewhat higher % elongation.
Performance testing by field laboratories indicated that P10 Special met or exceeded performance standards of traditional crown and bridge alloys being utilized.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 1999
Ms. Kathleen Calero President North American Alloys, Inc. 225 Brentwood Ct. Bloomingdale, IL 60108-2111
Re : K993344 Trade Name: P10 Special Requlatory Class: II Product Code: EJH September 28, 1999 Dated: Received: October 5, 1999
Dear Ms. Calero:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Calero
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
y A. Ulatows Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of of
K 993344 510(k) Number (if known): _
P10 Special Device Name: ___
...
Indications For Use:
For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-7-95)
Suan Puan
(Division Sign-Off) Division of Dental, It and General Hor 510(k) Number