(231 days)
Not Found
Not Found
No
The device description focuses on LED technology for curing dental materials and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is used for curing dental materials and activating tooth whitening materials, which are procedural applications rather than directly treating a disease or condition. While these applications assist in restorative dentistry, they are not primarily for therapeutic purposes.
No
Explanation: The device is described as a light source for curing dental materials and activating tooth whitening materials, which are therapeutic and restorative functions, not diagnostic.
No
The device description explicitly states it is a hand-held device with LEDs, batteries, and replacement tips, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's function is to provide light for curing dental materials and activating whitening materials. This is a therapeutic or procedural function, not a diagnostic one. It is used on the patient's oral cavity to facilitate a dental procedure, not to analyze a sample taken from the patient.
- Intended Use: The intended use is focused on the application and curing of dental materials, which is a direct intervention on the patient.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on the light interaction with the patient's tissues or materials.
Therefore, based on the provided information, the Palmlight is a dental device used for therapeutic/procedural purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A dental device intended to polymerize dental pit and fissure sealants or restorative materials by transmission of light via a light emitting diode.
Oral Applications: A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The Palmlight is a corded or cordless (battery operated) hand-held device. No filters are required to block out unnecessary rays. The light created by these diodes are specifically optimum for curing (430 to 500 nm). The Palmlight LED System is an instrument for use in the application of restorative compounds. sealants, and whitening compounds. The light is produced by a high intensity light emitting diode. With an adjustable light output of up to 500 Milliwatts. Therefore the applied for indications of use are warranted. Delivery devices (replacement tips) for the hand held probe are part of the package that allows the user to use the device with or without using direct current as rechargeable batteries are part of the handle. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral
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)
Clinical Performance Data None included with this submission.
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.
Ultradent Palmlight, Jetlite 4000
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
AUG 2 7 2002
CAO GROUP 8685 South 7th West Sandy, Utah 84070 (801) 256-9282 (801) 256-9287 (fax) Tracv S. Best. Consultant for Regulatory Affairs Preparation Date: January 03, 2002
Summary of Safety and Effectiveness for the:
Palmlight 410-490 nm Trade Name: Common Name: Dental curing light Classification Name: Activator, Ultraviolet, for Polymerization
Legally Marketed Predicate Devices for Substantial Equivalence:
-
Ultradent Palmlight, Distributed by Ultradent Products, Inc.
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Jetlite 4000, Manufactured by J. Morita USA, Inc.
Rationale for SE: The aforementioned devices and the accompanying delivery mechanisms share similar indications for use in oral application, similar design features including; light spectrum, and beam integrity. Control systems such as interlock devices, (safety systems) are constantly monitored for user intervention. Functional features such as delivery power and energy type are also similar to the aforementioned devices.
Description of Submitted Device:
The Palmlight is a corded or cordless (battery operated) hand-held device. No filters are required to block out unnecessary rays. The light created by these diodes are specifically optimum for curing (430 to 500 nm). The Palmlight LED System is an instrument for use in the application of restorative compounds. sealants, and whitening compounds. The light is produced by a high intensity light emitting diode. With an adjustable light output of up to 500 Milliwatts. Therefore the applied for indications of use are warranted. Delivery devices (replacement tips) for the hand held probe are part of the package that allows the user to use the device with or without using direct current as rechargeable batteries are part of the handle. .
Intended Uses of the Elite Family Lasers:
A dental device intended to polymerize dental pit and fissure sealants or restorative materials by transmission of light via a light emitting diode.
1
Technological Characteristics and Substantial Equivalence:
The Ultradent Palmlight is identical in features and light output. The variable light output and the ability to use the device with or without power cord (rechargeable batteries) is the same as the submitted device. Both the submitted device and this predicate device are used in the curing of composites that are photoactivated including restorative and whitening materials.
The Jetlite 4000 uses similar transmission of light technology with similar light output by a blue Light Emitting Diode (LED). The indications for use are the same. This and the submitted device are used in dentistry for the photo-activation and curing of dental composites.
Performance Standards
The Palmlight complies with the requirements of 21 CFR Sub Chapter J, as required by 21 CFR 1010.2
Clinical Performance Data
None included with this submission.
Conclusion:
The Palmlight System is substantially equivalent to other existing oral systems in commercial distribution. The Palmlight is designed to meet the electrical safety requirements of IEC 601-1. The high intensity light emitting diode is operated by logic circuitry. Therefore, we believe that the Palmlight is substantially equivalent to its predicate devices cited above without raising any new safety and/or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2002
Ms. Tracey S. Best Regulatory Consultant CAO Group, Incorporated 8685 South 7th West Sandy, Utah 84070
Re: K020057
Trade/Device Name: Palmlight Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 30, 2002 Received: June 4, 2002
Dear Ms. Best:
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.
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Page 2 - Ms. Best
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) 594-4618. 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,
Timo MA. Ulatowski 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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510(k) Number (if known):
Palmlight Device Name:
Indications For Use:
Oral Applications:
A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruane
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K002005
Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use __