(143 days)
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No
The summary describes a simple LED light curing device with no mention of AI or ML capabilities, image processing, or data analysis.
No
The device is used to cure dental materials, not to provide therapy to a patient.
No
The device is described as a high-intensity blue LED light source used to polymerize dental materials, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description explicitly states it is a "high intensity blue LED light source," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Easy-Curing™ is a light source used to cure dental materials outside of the body, directly in the patient's mouth. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for polymerizing dental materials, not for diagnostic testing of biological samples.
Therefore, the Easy-Curing™ falls under the category of a dental device, not an IVD.
N/A
Intended Use / Indications for Use
The Easy-Curing™ is a high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm, off the shelf, dental curing materials in the dentist's clinic.
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
dentist's clinic
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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§ 872.6070 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. Encircling the caduceus are the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Albelda President Dental Corporation Research and Development 7-11 South Broadway White Plains, New York 10601
APR 3 0 2007
Re: K063659
Trade/Device Name: Easy-Curing Pen-Style Led Curing Light Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: April 23, 2007 Received: April 23, 2007
Dear Mr. Albelda:
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.
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Page 2 - Mr. Albelda
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 your device to proceed to the market.
If you 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 yours.
Clues
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
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for "DENT CORP" with the tagline "Research & Development" underneath. The word "DENT" is in large, bold letters, followed by "CORP" which has a tooth graphic inside the "O". The "TM" symbol is located to the right of the "P" in "CORP", and the tagline is in a smaller, thinner font.
Indications for Use
510(k) Number: K063659
Device Name: Easy-Curing™
Indications For Use:
The Easy-Curing™ is a high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm, off the shelf, dental curing materials in the dentist's clinic.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
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Susan Rump
ा Sign-Off) Sign of Anesthesiology, General Hospital, Intection Control, Dental Devices 06 265 10(K) Number _
7-11 S. BROADWAY • WHITE PLAINS, NY 10601 • TEL: 1-800-454-9244 / 914-682-6600 • FAX: 914-948-1711