(51 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The intended use describes dental restorations (crowns, inlays, veneers, bridges) which are used to repair or replace teeth, not to treat a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section describes applications for dental restorations (crowns, inlays, veneer crowns, bridges), which are therapeutic or restorative procedures, not diagnostic ones. There is no information in the provided text that suggests the device is used for identifying or diagnosing a condition.
Unknown
The provided text is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The "Intended Use" section describes dental restorations, which are typically physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in creating dental restorations (crowns, inlays, bridges). This is a direct treatment or restorative function, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or other materials typically associated with in vitro testing
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided description clearly falls outside of this definition.
N/A
Intended Use / Indications for Use
¾ and single crowns, inlays, veneer crowns and short span bridges.
Product codes
EJT
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing a family or community, with their arms raised in a gesture of support or unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 2004
Ms. Cheryl V. Zimmerman Ms. Oner , Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K040043
Trade/Device Name: NDX-40 Regulation Number: 21 CFR 872.3060 Regulation Number: 21 CFK 872.5000
Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: January 08, 2004 Received: January 16, 2004
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) prematice is substantially equivalent (for the indications for referenced above and have determilied medicated predicated in interstate commerce
use stated in the enclosure) to legally market of the American Americas that use stated in the enclosure) to tegally filials Device Amendments, or to devices that prior to May 28, 1976, the enacthen clare of the Feleral Fore Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features in A. have been reclassified in accordance with the provisions of and application (PMA). You may,
Act (Act) that do not require approval of a premarket apprication (PMA). The gen Act (Act) that do not require approval or a premate approval spisions of the Act. The general
therefore, market the device, subject to the general controls provisions of the therefore, market the device, subject to the general online in the mass of devices, good
controls provisions of the Act include requirements for annial registration, controls provisions of the Act include requirements for and adulteration.
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 (PMA), it If your device is classified (see above) into entre regulations affecting your device can be
may be subject to such additional controls. An a regulations affecting your devic may be subject to such additional controls. Existing negal and 1999. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In found in the Code of I caeful reggarations, your device in the Federal Register.
1
Page 2 – Ms. Cheryl V. Zimmerman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a substance complies with other requirements of the Act of that FDA nas made a determination that your do Your Federal agencies. You must comply with any Pederal statutes and regulations administered by tecrees tration and listing (21 CFR Part 807); all the Act s requirements, mending, but not inner rece requirements as set forth in the quality labeling (21 CFR Fart 801), good manalazianny frashlicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod systems (QS) regulation (21-542 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 oegin maneting your and equivalence of your device to a legally premarket notification. The PDA midnig of sabbankal vice rand 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 advice for your device on our staditionally, for questions on the promotion contact the Office of Comphance at (301) 591-1000ffice of Compliance at (301) 594-4639 AMSO, ANGER and advertising of your device, preaso conado and by reference to premarket notification the Act m please note the regulation childer, "Inseralians" of the sun on your responsibilities under the Act may Part 807,977 you thay obtain. Other general macturers, International and Consumer Assistance at its be obtained from the Dryslers of or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu S. 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
2
Page_1_of__1_
11 040043 510(k) Number (if Known):
Device Name: NDX-40
Indications For Use: ¾ and single crowns, inlays, veneer crowns and short span bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _
(Optional Format 1-2-96)
Susan Riner
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of ontrol, Dental Devices
510(k) Number: K040043