(38 days)
Kerr Corporation, L.E. Demetron
Not Found
No
The description details standard electronic components and control logic (CPLD) for basic device functions, with no mention of AI or ML algorithms.
No
This device is for the polymerization of dental materials, not for diagnosing, treating, or preventing disease in patients.
No
The device is described as a light curing unit for polymerization of dental materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly details hardware components such as a handpiece, battery pack, charger, LED light source, cooling fan, circuit boards, and a CPLD chip. It is a physical device with embedded software controlling its functions, not a standalone software application.
Based on the provided information, the L.E.Demetron II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the polymerization of light cure materials by dental professionals. This describes a process performed directly on a patient's dental materials, not a test performed on a sample taken from the body.
- Device Description: The description details a light curing unit used to harden dental materials. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVD devices, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information about a patient's health status
The L.E.Demetron II is a therapeutic device used in a dental setting to facilitate a treatment process (polymerization of dental materials).
N/A
Intended Use / Indications for Use
The L.E.Demetron II is an L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Product codes
EBZ
Device Description
The L.E.Demetron II cordless curing light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery pack, a battery charger with built-in radiometer and a remote handpiece holder. The plastic molded handpiece contains an LED light source, a cooling fan and a digital electronic circuit consisting of surface mount components mounted on circuit boards. The handpiece functions, LED online cooling fan, display output, curing mode selection and low battery indicators, are controlled by the digital electronic circuit and a Complex Programmable Logic Device (CPLD) chiponionous of C into the control circuitry. The handpiece has a mode select button for activating the hondpoiece and selecting the desired curing mode. A second "trigger" button is used to activate the LED output. The handpiece is powered by a removable 4 cell, low voltage, Ni-MH battery pack. 22 volded plastic, triangular enclosure houses a printed circuit board with control circuitry for the battery charging function and the LED curing radiometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kerr Corporation, L.E. Demetron
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Above the logo are the numbers K0 51545. Below the logo, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller font.
JUL 1 8 2005
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: June 2005
Device Name:
- . Trade Name - L.E.Demetron II
- . Common Name - L.E.D. Curing Light
- Classification Name Ultraviolet activator for polymerization, per 21 CFR § 872.6070 ●
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, L.E. Demetron .
Device Description:
The L.E.Demetron II cordless curing light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery pack, a battery charger with built-in radiometer and a remote handpiece holder. The plastic molded handpiece contains an LED light source, a cooling fan and a digital electronic circuit consisting of surface mount components mounted on circuit boards. The handpiece functions, LED online cooling fan, display output, curing mode selection and low battery indicators, are controlled by the digital electronic circuit and a Complex Programmable Logic Device (CPLD) chiponionous of C into the control circuitry. The handpiece has a mode select button for activating the hondpoiece and selecting the desired curing mode. A second "trigger" button is used to activate the LED output. The handpiece is powered by a removable 4 cell, low voltage, Ni-MH battery pack. 22 volded plastic, triangular enclosure houses a printed circuit board with control circuitry for the battery charging function and the LED curing radiometer.
Intended Use of the Device:
The intended use of L.E.Demetron II is for the polymerization of visible light cured materials.
Substantial Equivalence:
The L.E.Demetron II is substantially equivalent to other legally marketed devices in the United States. The L.E. Demetron II functions in a manner similar to and is intended for the same use as the L.E. Demetron designed by Kerr Corporation.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2005
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K051545
Trade/Device Name: L.E. Demetron II Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 08, 2005 Received: June 10, 2005
Dear Ms. Boswell:
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.
2
Page 2 - Ms. Colleen Boswell
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" (21 CFR 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,
Signature
Chiu S. Lin, PhD 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 (if known): K (5 1545
Device Name: L.E.Demetron II
Indications for Use:
The L.E.Demetron II is an L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S. Betz, Jr. MD for Dr. Susan Runner
(Division Sign-C Division of Anesthesiology, General Hosp Infection Control, Dental De
510(k) Number: K051545 the text in the image is: