(70 days)
Optilux 400
Not Found
No
The description details a standard light curing unit with basic electronic controls and a radiometer, with no mention of AI or ML components or functions.
No
The device is used for polymerization and activation of dental materials, not for treating any specific disease or condition. It facilitates a dental procedure rather than directly providing therapy.
No
The device description states its intended uses are for "polymerization of light cure materials and activation of dental bleaching materials", which are treatment functions, not diagnostic ones. The device has an "integrated curing radiometer," but its purpose is for curing, not diagnosis.
No
The device description clearly outlines physical hardware components including a control unit, hand piece, power cord, transformer, circuit boards, lamp, optical filter, fiber optic light guide, and micro-switch. This is not a software-only device.
Based on the provided information, the Optilux 501 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the polymerization of light cure materials and activation of dental bleaching materials. These are procedures performed directly on or in the patient's mouth, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a device that emits light for curing and activation. It does not describe a device that analyzes biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a patient's health status.
Therefore, the Optilux 501 is a dental device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
- Not Found
Intended Use / Indications for Use
The Optilux 501 is a device used for the polymerization of dental materials using visible light.
The Optilyx 501 is for the polymerization of light cure materials and activation of dental bleaching materials.
The Optilux 501 is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The Optilux 501 is a device used for the polymerization of dental materials using visible light. It consists of a control unit and cord connected hand piece. The molded plastic control unit contains a power inlet receptacle for a detachable mains power cord, fuse holders and fuses, mains wiring, mains supply isolation transformer, printed circuit board with control circuitry for lamp and cooling fan functions and an integrated curing radiometer. The cord connected molded plastic hand piece contains a low voltage halogen lamp, optical filter assembly and fiber optic light guide that generates visible (blue-white) light energy having the wavelength range of approximately 400nm -505 nm. The hand piece also contains 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Optilux 400
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K0 20091
Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple font. The words 'Safety and Effectiveness' are printed below the company name.
MAR 2 1 2002
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 501 .
- 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 501 is a device used for the polymerization of dental materials using visible light. It consists of a control unit and cord connected hand piece. The molded plastic control unit contains a power inlet receptacle for a detachable mains power cord, fuse holders and fuses, mains wiring, mains supply isolation transformer, printed circuit board with control circuitry for lamp and cooling fan functions and an integrated curing radiometer. The cord connected molded plastic hand piece contains a low voltage halogen lamp, optical filter assembly and fiber optic light guide that generates visible (blue-white) light energy having the wavelength range of approximately 400nm -505 nm. The hand piece also contains a small printed circuit board with a micro-switch for activation of the curing lamp.
Intended Use of the Device:
The intended use of the Optilyx 501 is for the polymerization of light cure materials and activation of dental bleaching materials.
Substantial Equivalence:
Optilux 501 is substantially equivalent to other legally marketed devices in the United States. Optilux 501 functions in a manner similar to and is intended for the same use as the Optilux 400 designed by Kerr Corporation.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Kerr Corporation Ms. Colleen Boswell C/O Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K020091
Trade/Device Name: Optilux 501 Regulation Number: 872.6070 Regulation Name: Curing Light Regulatory Class: II Product Code: EBZ Dated: January 7, 2002 Received: January 10, 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.
2
Page 2 - Ms. Boswell
You must comply with a!l 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,
K. Walorski
Timothy A. Ulatowski 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): | Ko 20091 |
Device Name: Optilux 501
Indications For Use:
The Optilux 501 is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
Susan Runpa
sion Sign-Off)
sion of Dental, Infection Control,
General Hospital Devices
| Labels | Values |
|---|---|
| k) Number | R02009) |
(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