(36 days)
This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.
This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.
I apologize, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Aalba Dent, Incorporated for their Continum™ dental alloy. It primarily confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, or retrospective/prospective study design.
- Information on the number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
- Data on standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes).
- The sample size for the training set.
- How the ground truth for the training set was established.
The letter only states the device name (Continum™), its regulation name (Base Metal Alloy), regulatory class (Class II), and its intended use (a non-precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crowns and bridges). It indicates that the FDA has determined the device to be substantially equivalent.
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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Mr. Vincent M. Benetti Vice President, General Manager Aalba Dent, Incorporated 400 Watt Drive Cordelia, California 94534
Re: K040179
Trade/Device Name: Continum™ Trade/Dion 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 to We have reviewed your Section 500(k) premarket in this to ntalent (for the indications for referenced above and have determined the devices marketed in therstate commence
use stated in the enclosure) to legally marketed predicate devices marketed in use stated in the enclosure) to legally marketed previews manded mass of to devices that
prior to May 28, 1976, the enactment date of the Federal Food, Drug, I prior to May 28, 1976, the enactment date of the Medical Device I handali, bug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal Food. Dru have been reclassified in accordance with the provisions of me redication (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the A Act (Act) that do not require approval of a premiere approval appovisions of the eeneral
therefore, market the device, subject to the general controls provisions of the estab the ( market the device, subject to the general controls or alle from the research in the research and advices, good
controls provisions of the Act include requirements for a controls provisions of the Act include requirements for animals region.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The manufactu
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (special concoln) on one of ( < < < < < < < < < < < < < < < < < < < < < < < < < < < may be subject to such additional controls. Existing major and and and one of the may publish
found in the Code of Federal Regulations, Title 2, Parts 800 to 898. In additi found in the Code of Federal Regulations, Title = 7
further 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 Please be advised that ITDA 3 Issualled of a substantial copyines with other requirements of the Act of that FUA hade a decemination that your read your rederal agencies. You must comply with (1) CEP Page 807) any Federal statures and regulations administred of to: registration and listing (21 CFR Part 817); all the Act s requirements, menuding, but novine on actice requirements as set forth in the quality labeling (21 CFR Part 801); good manager and if applicable, the electronic product radiation systems (QB) 10g ... 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 his letter will anow you to ogin maneting of substantial equivalence of your device to a legally premarket notification. "The PDF Intently of vour 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 If you desire specific aurice for your de rice of the staditionally, for questions on the promotion contact the Office of Compliance ares contact the Office of Compliance at (301) 594-4639. Also, and advertising of your device, prease verranding by reference to premarket notification" (210FR) please note the regulation childer, "Misolanding of risens on your responsibilities under the Act may Patt 807.97 you they obtain. Other generantacturers, International and Consumer Assistance at its be obtained from are ) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
C. Lin, Ph.D.
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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K040179 510(k) Number (if known):
Continum Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
This device is a non precious, nickel-chromium-molybdenum-beryllium based rino were wor alloy for use in the construction of cast ceramic bonded crown echanie basing anog anoyy and of the may 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)
Susan Runner
ivision Sign-Off ision of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number. K04079
Prescription Use -
OR
Over-The-Counter Use
(per 21 CFR 801.109)
(optional format 1-2-96)
§ 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.