TRANSCURE, MODEL 2910

K022862 · Kinetic Instruments, Inc. · EBZ · Oct 18, 2002 · Dental

Device Facts

• Record ID: K022862
• Device Name: TRANSCURE, MODEL 2910
• Applicant: Kinetic Instruments, Inc.
• Product Code: EBZ · Dental
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

Light Activation System for Dental Restorative Resins Visible Inspection of the Oral Cavity

Device Story

TransCure is a dental light activation system; functions as a light source for curing restorative resins and illuminating the oral cavity. Operated by dental professionals in a clinical setting. Device emits light to initiate polymerization of dental materials; provides visibility for oral examinations. Benefits include efficient resin curing and improved visualization during dental procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultraviolet/visible light activation system for dental polymerization. Form factor designed for clinical dental use. Operates as a light source for resin curing and oral cavity illumination.

Indications for Use

Indicated for dental professionals to cure light-activated restorative resins and to provide illumination for visual inspection of the oral cavity.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2002

Mr. William J. Becker President Kinetic Instruments, Incorporated 17 Berkshire Boulevard Bethel, Connecticut 06801

Re: K022862

Trade/Device Name: TransCure Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 28, 2002 Received: August 28, 2002

Dear Mr. Becker:

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 cither 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.

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.

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## Page 2 - Mr. Becker

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Glutornl

Timothy A. Ulatowski 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 STATEMENT

Ver/ 3 - 4/24/96

Applicant: Kinetic Instruments Inc.

510(k) Number (if known): N/A

Device Name: TransCurc

Indications For Use:

Light Activation System for Dental Restorative Resins Visible Inspection of the Oral Cavity

Susan Runys

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

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