(64 days)
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No
The summary provides no information suggesting the use of AI or ML. The intended use and lack of mentions of AI/ML, image processing, or performance studies related to algorithmic analysis indicate a standard light-curing device.
No
The device is used for the polymerization of dental materials, which is a functional process rather than a direct treatment or diagnosis of a medical condition.
No
Explanation: The device is intended for the polymerization of light-curing dental materials, which is a treatment or curing function, not a diagnostic one.
No
The intended use describes a device for the polymerization of light-curing dental materials, which strongly suggests a hardware component (a light source) is involved. The lack of a device description prevents confirmation, but the function described is not typically performed by software alone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm." This describes a device used to harden dental materials outside of the human body, but it's a physical process applied to a material, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Measuring biomarkers or other indicators of disease
An IVD is a medical device used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to process dental materials, which are not biological samples used for diagnosis.
N/A
Intended Use / Indications for Use
For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.
Product codes
EBZ
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.
JUN 1 2 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna Marie Hartnett Director, Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K091020
Trade/Device Name: bluephase® 20i Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 7, 2009 Received: April 29, 2009
Dear Ms. Hartnett:
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 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.
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Page 2 - Ms. Hartnett
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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Swar Russer
Radiological Health
Susan Runner, D.D.S. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: bluephase® 20i Indications For Use:
For the polymerization of light-curing dental materials curing in the wavelength range of 380-515 nm.
2091020
Prescription Use 6 AND/OR_ Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
freurrence of CDRH, Office of Device Evaluation (ODE) are (Division Sign-Off) Page 1 of (Division Sign-Off)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
510(k) Number: K091020