(143 days)
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.
The Easy-Curing™ is a high intensity blue LED light source.
This document is a 510(k) clearance letter for the "Easy-Curing Pen-Style Led Curing Light" and does not contain the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness (SSE) document. Therefore, I cannot provide a complete answer to your request based solely on the provided text.
Specifically, the document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not describe a new study conducted to establish performance beyond that. It primarily details regulatory information, product classification, and indications for use.
Here's what I can extract and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document as quantitative performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices for its intended use of polymerizing dental materials.
- Reported Device Performance: The document states the device 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." No specific performance metrics (e.g., light intensity, curing depth, bond strength measurements) are provided within this letter. Such data would typically be in the 510(k) submission itself, not the clearance letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This document does not detail any specific test set or data provenance from a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. This information would pertain to a specific study, which is not described here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a curing light, not an AI-assisted diagnostic tool or an imaging device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (curing light), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. For a curing light, ground truth would likely involve laboratory measurements of curing efficacy, such as hardness, depth of cure, or bond strength, compared to a reference standard. This information is not in the provided text.
8. The sample size for the training set:
- Not applicable/Not provided. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
In summary, the provided FDA 510(k) clearance letter confirms regulatory approval based on substantial equivalence but does not contain the detailed study results or performance data that would address your specific questions about acceptance criteria and study methodology. Such information would be found in the original 510(k) submission documentation, which is not included here.
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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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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
§ 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.