(101 days)
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No
The summary describes a dental alloy material and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an alloy for the construction of cast crown and bridge prosthetic devices, which are restorative rather than therapeutic.
No
This device is described as a "Type III alloy for use in the construction of cast crown and bridge prosthetic devices," indicating it is a material used in the creation of dental restorations, not for diagnosing conditions.
No
The device description clearly states it is a "non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy," 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 construction of cast crown and bridge prosthetic devices, which are used in the mouth for dental restoration. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a metal alloy used to create dental prosthetics. This is a material used in the body, not a test performed on a sample from the body.
- Classification: The device is classified as a "Base Metal Alloy" under 21 CFR Part 872, which relates to dental devices. IVDs are classified under different parts of 21 CFR, typically Part 866 (Immunology and Microbiology Devices) or Part 864 (Hematology and Pathology Devices).
Therefore, this device falls under the category of a dental prosthetic material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.
Product codes
EJH
Device Description
VeraSoft ES is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy.
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
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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): 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.
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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.
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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).
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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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Mr. Vincent Benetti Vice President Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94534
Re: K033356
Trade/Device Name: Verasoft ES Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: September 16, 2003 Received: October 22, 2003
Dear Mr. Benetti:
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 approvisions 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 adultcration.
If your device is classified (see above) into cither class 11 (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. Benetti
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 modified in 21 man may Federal statutes and regulations administered by other Federal agencies. of the Fiel of all , 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 and insuite (2) es ret 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 premitated 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), nlease contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Mishranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.
Patricia Cucurullo
Chiu Lin, Ph.D. 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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KO3356
Page _ 1 __ of __ 1 _
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________ VeraSoft ES
Indications For Use:
This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluations (ODE)
Angela Blackwell for MSR
510(k) Number:
Prescription Use
OR
Over-The-Counter Use
(per 21 CFR 801.109)
(optional format 1-2-96)