(71 days)
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Not Found
No
The summary describes a metal alloy used for fabricating dentures and contains no mention of AI or ML.
No
The device is an alloy used for fabricating dentures, which are restorative devices, not therapeutic devices.
No
Explanation: The device is an alloy intended for fabricating dental appliances, not for diagnosing medical conditions.
No
The device is described as a cobalt-chromium based alloy in nugget form, 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 removable denture appliances. This is a manufacturing process for a medical device that will be used in the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The device is a material (cobalt-chromium alloy) in a specific form (nugget). This is a component used in the creation of a medical device, not a diagnostic test itself.
- 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.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, VERA PDN is a material used in the manufacturing of a medical device (dentures), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for the fabrication of custom-made removable denture appliances.
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
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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)
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Reference Device(s)
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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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aalba Dent, Incorporated C/O Robert W. Bauer, Ph.D. 1819 South May Street, 2F Chicago, Illinois 60608 --
AUG 1 5 1997
K972118 Re : Trade Name: Vera PDN Requlatory Class: II Product Code: EJH Dated: June 2, 1997 Received: June 5, 1997
Dear Dr. Bauer:
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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 obligation you might have under sections 531
1
Page 2 - Dr. Bauer
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 qeneral 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,
K. Clatrust.
Timoth x A. Ul Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page / of /
977118 510(k) Number (if known): K
VERA PDN Device Name:
Indications For Use:
VERA PDN, a cobalt-chromium based alloy in nugget form, is VERA PDN, a cobart-chiomical based arroy 2007 by and of custom-made removable denture appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Rumpes
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972118
Prescription Use V (Per 21 CFR 801.109)
ીરા
Over-The-Counter Use___________
(Optional Format 1-2-96)
$K=50
$\frac{DE}{H}$