(37 days)
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Not Found
No
The summary describes a dental alloy, a material used in prosthetics, with no mention of software, algorithms, or any computational processing that would involve AI or ML.
No
The device is described as an alloy for constructing dental prosthetic devices (crown and bridge), not a device used therapeutically to treat a disease or condition.
No
Explanation: The device is described as an alloy for constructing prosthetic dental devices (crown and bridge), not for identifying or diagnosing a condition.
No
The device description clearly states it is a "non precious, nickel-chromium-molybdenum-berylium based ceramic casing 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 clearly states it's a material for constructing dental prosthetic devices (crown and bridge). This is a structural material used in the body, not a device used to test samples from the body.
- Device Description: The description reinforces that it's a metal alloy for dental prosthetics.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
Therefore, this device falls under the category of a dental material or prosthetic component, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prostheses.
Product codes
EJH
Device Description
This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prostheses.
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
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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.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human profiles or birds in flight. The shapes are stacked on top of each other and are black in color.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2004
Mr. Vincent M. Benetti Vice President, General Manager Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94534
Re: K040180
Trade/Device Name: Continum™ V Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: January 23, 2004 Received: January 27, 2004
Dear Mr. Benetti:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave feviewed your Docton 910th production is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the eneround date of the Medical Device Amendments, or to devices that provide in May 26, 1770, the onleanent uith the provisions of the Federal Food, Drug, and Cosmetic nave bech techassified in woenanced of a premarket approval application (PMA). You may, Act (Act) that ao not require apple to the general controls provisions of the Act. The general therefore, mailed the detired, babyer se assimments for annual registration, listing of devices, good Controls provisions of cliebeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de vice is classified (600 as 10) into Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish fourther announcements concerning your device in the Federal Register.
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Page 2 - Mr. Vincent M. 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 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) I mis letter writing on The FDA finding of substantial equivalence of your device to a legally premated noticated on 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 11 you don't be 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) you may obtain. 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,
Chih S. Lin, PhD
Chiu S. Lin, PhD 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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11040180 510(k) Number (if known):
Continum V Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
This device is a non precious, nickel-chromium-molybdenum-berylium based This aevice is a non presious, mento on truction of cast ceramic bonded crown ceramic casing anoy for use in the coline to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872, and bridge prosinent acrices: "Reserving the group" 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)
Susan Ruoper
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number:
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(per 21 CFR 801.109)
(optional format 1-2-96)