REMECURE MODEL CL 15E

• K Number: K023652
• Device Name: REMECURE MODEL CL 15E
• Manufacturer: REMEDENT NV
• Date Cleared: 2003-01-09 ( 71 days)
• Product Code: EBZ
• Regulation Number: 872.6070
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Remecure CL-15E produces visible light for the polymerization of dental materials and for tooth whitening.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Remecure CL-15E device, which is an Ultraviolet Activator for Polymerization.

This type of document primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. While it details the device name, regulation number, and indications for use, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about any specific study (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for test or training sets).

The FDA's substantial equivalence determination for 510(k) devices often relies on comparisons to predicate devices that have already demonstrated safety and effectiveness, rather than requiring extensive new clinical trial data that would outline such detailed study parameters.

Summary

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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: [phone] - Fax: [phone]

Regulation Number and Section

§ 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.