(63 days)
Not Found
Kerr Corporation, Optilux 400
No
The description details standard electronic and optical components for light curing, with no mention of AI or ML algorithms, data processing, or learning capabilities.
No
The device is used for polymerization of dental materials, which is a functional purpose, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is described as a visible light curing unit intended for the polymerization of light cure materials, not for diagnosing medical conditions. While Model 380 has "radiometer functions," the primary purpose stated is curing, not diagnosis.
No
The device description clearly outlines physical hardware components including control units, handpieces, printed circuit boards, lamps, fans, power cords, and fiber optic light guides. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for polymerization of light cure materials." This describes a process applied to materials outside the body, specifically dental materials.
- Device Description: The description details a light curing unit used to harden dental materials. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic results.
- Measuring analytes in biological samples.
Therefore, the Optilux Curing Lights are dental devices used for a therapeutic/restorative purpose (hardening dental materials), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Optilux Curing Lights are visible light curing units intended for polymerization of light cure materials.
Product codes
EBZ
Device Description
The Optilux Curing Lights, Models 380, 401 and 405, are devices used for the polymerization of dental materials using visible light. They consist of a control unit and cord connected handpiece. The molded plastic control units house the printed circuit board with control circuitry for the lamp and cooling fan. Additionally, the printed circuit board for the Model 380 contains control circuitry for radiometer functions. Model 380 also has a permanently attached power cord, however the power cords on Models 401 and 405 are detachable. The handpiece cord attached to the Model 405 is separable by a panel mount connector, which allows the control unit to be installed inside a cabinet or dental chair.
The molded plastic handpieces contain a low voltage halogen lamp, optical filter assembly and a fiber optic light guide that generates visible (blue-white) light energy having a bandwidth of approximately 400 - 515 nm. The handpieces also contain a small printed circuit board with a micro-switch for activation of the curing lamp.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Kerr Corporation, Optilux 400
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
MAR 2 9 2002
120267
SYBRON DENTAL SPECIALTIES
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: January 2002
Device Name:
- Trade Name Optilux Curing Lights .
- Common Name 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 Optilux Curing Lights, Models 380, 401 and 405, are devices used for the polymerization of dental materials using visible light. They consist of a control unit and cord connected handpiece. The molded plastic control units house the printed circuit board with control circuitry for the lamp and cooling fan. Additionally, the printed circuit board for the Model 380 contains control circuitry for radiometer functions. Model 380 also has a permanently attached power cord, however the power cords on Models 401 and 405 are detachable. The handpiece cord attached to the Model 405 is separable by a panel mount connector, which allows the control unit to be installed inside a cabinet or dental chair.
The molded plastic handpieces contain a low voltage halogen lamp, optical filter assembly and a fiber optic light guide that generates visible (blue-white) light energy having a bandwidth of approximately 400 - 515 nm. The handpieces also contain a small printed circuit board with a micro-switch for activation of the curing lamp.
1
Intended Use of the Device:
The intended use of the Optilux Curing Lights are for the polymerization of light cure materials.
Substantial Equivalence:
The Optilux Curing Lights are substantially equivalent to other legally marketed devices in the United States. The Optilux Curing Lights function in a manner similar to and are intended for the same use as the Optilux 400 designed by Kerr Corporation.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three abstract figures, possibly representing people, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
MAR 2 9 2002
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92667
Re: K020267
Trade/Device Name: Optilux Curing Lights Regulation Number: 872.6070 Regulation Name: Ultaviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 22, 2002 Received: January 25, 2002
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.
3
Page 2 - Ms. 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,
Patricia Cucentiffor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section I
ﺔ ﺍﻟﻤﺘﺤﺪﺓ
Indications for Use Statement
| Ver/3 - 4/24/96 | |
|---|---|
| Applicant | Kerr Corporation |
| 510(k) Number (if known): | |
| Device Name: | Optilux Curing Lights |
| Indications For Use: |
The Optilux Curing Lights are visible light curing units intended for polymerization of light cure materials.
Susan Rinn
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K020267 |
|---|---|
| --------------- | --------- |
(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)