(52 days)
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No
The summary describes a dental core build-up material and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is used for core build-up of teeth, which is a restorative dental procedure, not a therapeutic one aimed at treating a disease or condition.
No
The device description indicates its purpose is for core build-up of teeth, which is a treatment or restorative procedure, not a diagnostic one.
No
The intended use describes a material for core build-up of teeth, which is a physical substance, not software. The lack of information in other sections further supports this conclusion.
Based on the provided information, it is highly unlikely that Rebilda DC is an IVD.
Here's why:
- Intended Use: The intended use is "for core build-up of vital and non-vital teeth." This describes a dental procedure performed directly on the patient's teeth, not a test performed on a sample taken from the body.
- Anatomical Site: The anatomical site is "teeth," which aligns with a dental device used in vivo.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Diagnosing a condition based on sample analysis
- Any laboratory procedures
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Rebilda DC's intended use and description do not fit this definition.
Therefore, Rebilda DC appears to be a dental restorative material used in a clinical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Rebilda DC is intended for core build-up of vital and non-vital teeth
Product codes
EBF
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
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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
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the bird figure in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 3
Dr. Michael Sües Manager for Regulatory Affairs VOCO GmbH Anton-Flettner-Straße 1-3 27472 Cuxhaven, GERMANY
Re: K060893
Trade/Device Name: Rebilda DC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 4, 2006 Received: May 8, 2006
Dear Dr Sües:
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 controls provisions 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 adulteration.
If your device is classified (see above) into either class II (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.
1
Page 2 - Dr. Sües
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) 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 vour device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 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/industry/support/index.html.
Sincerely vours.
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
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Indications for Use Statement
510(k) Number:
Device Name: Rebilda DC
Indications for Use:
Rebilda DC is intended for core build-up of vital and non-vital teeth
Prescription Use __X
OR
Over-The-Counter Use __
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runge
Ancelliestology, General Hi n Connol, Dental Devi