(320 days)
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No
The summary describes a dental composite material, which is a passive material and does not incorporate AI/ML technology. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a dental composite material used for direct esthetic restorations, which is a restorative rather than therapeutic function. It doesn't treat a disease or condition; it replaces lost tooth structure.
No
The device is a "Microhybrid Composite" intended for "direct esthetic restoration," which indicates it is a restorative material used in treatment, not for diagnosing conditions.
No
The device description clearly states "Microhybrid Composite," which is a material used in dental restorations, indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct esthetic restoration in the anterior and posterior regions of the mouth, specifically for dental restorations. This is a direct treatment applied to the patient's body.
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens or providing diagnostic information based on such analysis.
Therefore, the Microhybrid Composite, as described, is a dental restorative material used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
Microhybrid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class i, II, III, IV, and V, and diastema closure.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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/0 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 symbol that resembles an abstract representation of human figures or forms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 11, 2012
Ms. Cora Bracho-Troconis Regulatory Affairs Analyst Novocol, Incorporated 416 South Taylor Avenue LOUISVILLE CO 80027
Re: K120237
Trade/Device Name: Microhybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 15, 2012 Received: November 16, 2012
Dear Ms. Bracho-Troconis:
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. 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
1
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,
Kwame Ó. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510K number (if known): K120237
Device Name: Microhybrid Composite
Indications for Use:
Microhybrid Composite is indicated for direct esthetic restoration in the anterior and posterior regions. This composite can be used in all direct dental restorations, Class i, II, III, IV, and V, and diastema closure.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.11
Susan Runner DDS, MA 14:57:21
-05'00'
്വിvision Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
K120237 510(k) Number:
3
Indications for Use Statement
510K number (if known): / /20237
Device Name: Microhybrid Composite
Indications for Use: ·
Microhybrid Composite is indicated for direct esthetic restoration in the anterior and Micronio regions. This composite can be used in all direct dental restorations, Class I, II, III, IV, and V, and diastema closure.
Prescription Use × (Part 21 CFR 801 Subpart D)
C
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner DDs, MA: 2012.12.10
Susan Runner DDs, MA: 2012.12.10 -05 12:22:08 -05 00'
Ulvision Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number;_