(86 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use for intraoral repairs of dental restorations.
No
The device is described as being for "intraoral repairs of defects in ceramic or composite veneer," which pertains to dental restoration materials rather than directly treating a medical condition or disease.
No
The "Intended Use / Indications for Use" section describes the device as being used for "Intraoral repairs of defects" in various dental materials, which is a therapeutic or restorative function, not a diagnostic one. There is no mention of identifying, detecting, or assessing conditions.
No
The provided text describes a material (Cimara and Cimara Zircon) used for intraoral repairs of dental restorations. It does not mention any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for intraoral repairs of dental restorations (veneers, fixed prosthetics, inlays). This is a direct application within the patient's mouth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The device described here does not involve testing biological samples.
- Lack of IVD Keywords: The description does not mention any terms related to laboratory testing, biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, the intended use and description point to a device used for dental restoration and repair within the oral cavity, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Cimara:
- Intraoral repairs of defects in ceramic or composite veneer, fixed, prosthetic work with . metal frames.
Cimara Zircon: - Intraoral repairs of defects in ceramic veneer, fixed, all-ceramic restorations on . zirconium oxide frames and other oxide ceramics
- Intraoral repairs of fractures on ceramic and composite inlays .
Product codes
EBF, KLE
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
Not Found
§ 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 & Human Services (HHS). The logo features a stylized eagle with three stripes representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Manfred T. Plaumann Managing Director VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY
MAY 2 7 2011
Re: K110589
Trade/Device Name: Cimara and Cimara Zircon Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and KLE Dated: February 25, 2011 Received: March 2, 2011
Dear Mr. Plaumann:
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-premarketapproval 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Plaumann
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to . http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runner
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: K110584
Device Name: _ Cimara and Cimara Zircon
Indications for Use:
Cimara:
- Intraoral repairs of defects in ceramic or composite veneer, fixed, prosthetic work with . metal frames.
Cimara Zircon:
- Intraoral repairs of defects in ceramic veneer, fixed, all-ceramic restorations on . zirconium oxide frames and other oxide ceramics
- Intraoral repairs of fractures on ceramic and composite inlays .
| 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 Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110589