(83 days)
Not Found
No
The description details a device with a microprocessor controlling pre-programmed curing modes based on time, not adaptive or learning algorithms.
No
The device is described as a light curing unit for polymerization of dental materials, not for direct therapeutic treatment of a patient's disease or condition.
No
Explanation: The device is described as a "visible light curing unit intended for polymerization of light cure materials" and is used to "activate the LED curing output". This function is therapeutic, not diagnostic.
No
The device description explicitly states it consists of a handpiece containing hardware components like an LED light "engine", cooling fan, printed circuit board, digital circuit, and microprocessor, in addition to the software controlling its functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the polymerization of light cure materials by dental professionals. This is a direct treatment or procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a light curing unit used to harden dental materials. This is a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly a tool used in a dental procedure to cure materials, which falls under the category of a therapeutic or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Demi 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 Demi is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cured materials by dental professionals. The Demi consists of an LED curing handpiece and charging system. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output, fan, and audible beep timing. The Demi utilizes two pushbutton triggers, one to select the curing mode and another to activate the LED curing output.
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 II
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 with the letters 'sds' in a stylized font. A curved line extends over the letters. The letters are bold and black. The logo appears to be for a dental practice.
SYBRON DENTAL SPECIALTIES
JUL 26 2007
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: May 2007
Device Name:
- Trade Name Demi .
- 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 II
Device Description:
The Demi is a Light Emitting Diode (LED) visible light curing unit used for the polymerization of light-cured materials by dental professionals. The Demi consists of an LED curing handpiece and charging system. The plastic molded handpiece will contain an LED light "engine", a cooling fan and a printed circuit board. A digital circuit and microprocessor will be utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output, fan, and audible beep timing. The Demi utilizes two pushbutton triggers, one to select the curing mode and another to activate the LED curing output.
Intended Use of the Device:
The intended use of Demi is for the polymerization of visible light-cured materials by dental professionals.
Substantial Equivalence:
Demi is substantially equivalent to other legally marketed devices in the United States. Demi functions in a manner similar to and is intended for the same use as the L.E. Demetron II designed by Kerr Corporation.
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Image /page/1/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 a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2007
Kerr Corporation C/O Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue
Re: K071251
Orange, California 92867
Trade/Device Name: Demi Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 25, 2007 Received: June 26, 2007
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.
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Page 2 - Ms. 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" (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 vours.
Sudite 4. Michael MD.
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 (if known):
Device Name: Demi
Indications for Use:
The Demi 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)
| (Section Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | Page 1 of 1 |
| 510(k) Number: | K071251 |
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