(46 days)
Kerr Corporation, Optilux 400
Not Found
No
The description details a simple light curing unit with basic controls and a timer, with no mention of AI/ML terms or functionalities.
No
The device is described as a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials, which are functions related to preparing or processing materials, not directly treating a disease or condition in a patient.
No
The device description states its use is for the "polymerization of dental materials" and "activation of dental bleaching materials," which are treatment functionalities, not diagnostic ones.
No
The device description clearly outlines physical hardware components (gun, base stand, cord, switch, beeper, fan, trigger) which are integral to its function.
Based on the provided information, the Demetron LC is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the polymerization of light cure dental materials and activation of dental bleaching materials. This is a direct treatment or procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a light curing unit used for dental procedures. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Mentioning reagents or assays
Therefore, the Demetron LC is a dental device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Demetron LC is for the polymerization of light cure materials and activation of dental bleaching materials.
The Demetron LC is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
Product codes
EBZ
Device Description
The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.
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
Not Found
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, Optilux 400
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.
0
FEB 0 4 2002
Image /page/0/Picture/1 description: The image is a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a swoosh above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a simple sans-serif font. The logo is black and white.
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: December 2001
Device Name:
- Trade Name Demetron LC .
- Common Name Low Cost Curing Light .
- Classification Name Ultraviolet activator for polymerization, per 21 CFR § 872.6070 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Optilux 400 .
Device Description:
The Demetron LC curing light is a device used for the polymerization of dental materials. It consists of a gun and a base stand connected by a cord. The base stand will contain an on/off switch, a gun hanger, and a beeper that generates an audible tone at ten second intervals. The gun trigger will turn the light on until the trigger is actuated again to turn off. The fan will run continuously whenever the unit is on.
Intended Use of the Device:
The intended use of the Demetron LC is for the polymerization of light cure materials and activation of dental bleaching materials.
Substantial Equivalence:
Demetron LC is substantially equivalent to other legally marketed devices in the United States. Demetron LC functions in a manner similar to and is intended for the same use as the Optilux 400 designed by Kerr Corporation.
1717 West Collins Avenue, Orange, CA 98867 800-537-7824 714-516-7400
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2002
Kerr Corporation C/O Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K014179
Trade/Device Name: Demetron LC Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: December 18, 2001 Received: December 20, 2001
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.
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.
2
Page 2 - Ms. Colleen Boswell
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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
Tin Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I
Indications for Use Statement
Ver/3-4/24/96
Applicant: Kerr Corporation
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K014179 |
| Device Name: | Demetron LC |
Indications For Use:
The Demetron LC is a visible curing unit intended for polymerization of light cure materials and
activation of dental bleaching materials.
Susan Figurer
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| Labels | Values |
|---|---|
| 510(k) Number | K014179 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)