(71 days)
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No
The summary describes a light-curing device for dental materials and tooth whitening, with no mention of AI or ML capabilities.
No
The device is used for polymerization of dental materials and tooth whitening, which are cosmetic or restorative procedures, not therapeutic in nature for treating a disease or condition.
No
Explanation: The device is described as producing visible light for the polymerization of dental materials and for tooth whitening. This is a treatment function, not a diagnostic one.
No
The intended use describes a device that produces visible light, which is a hardware function, not a software-only function.
Based on the provided information, the Remecure CL-15E is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "produces visible light for the polymerization of dental materials and for tooth whitening." This describes a device used directly on a patient's teeth for treatment purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Remecure CL-15E does not perform any such tests on bodily samples.
The device's function is a light source for dental procedures, which falls under the category of a therapeutic or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2003
Remedent NV C/O Mr. Ed First Director of Engineering and Quality DME Dezigns 20992 Bake Parkway, Unit 102 Lake Forest, California 92630
Re: K023652
Trade/Device Name: Remecure CL-15E Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: July 11, 2002 Received: October 30, 2002
Dear Mr. First:
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. First
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows a logo with the text "DME designs". The letters "DME" are large and bold, with a thick black line underneath them. Below the line, the word "designs" is written in a smaller font, with the "Z" in "designs" being emphasized with a different font style and an underline.
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (As required by 21 CFR 807.92)
510(K) Number: K023652
Device Name: Remecure CL-15E
Indications for Use:
The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| Suser Reaver | |
| K023652 | |
| (510(k) Number) |
Prescriptive Use
(Per 21CFR 801.109)
20992 Bake Pkwy.#102 Lake Forest, CA 92630 Phone: 949-421-0121 - Fax: 949-421-0122