(14 days)
Not Found
None
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use is a simple polymerization function.
No
The device is intended for the polymerization of light cure materials, which is a functional process rather than a direct therapeutic intervention for a disease or condition.
No
The intended use explicitly states "for the polymerization of light cure materials," which is a treatment or manufacturing process, not a diagnostic one.
No
The intended use describes the polymerization of light cure materials, which is a physical process typically performed by a hardware device (a light curing unit). There is no mention of software as the primary or sole component.
Based on the provided information, the BlueLEX LD-105 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The stated intended use is "for the polymerization of light cure materials." This describes a function related to curing or hardening materials, typically in a dental or other material science context.
- Lack of IVD Characteristics: The description does not mention anything related to:
- Examining specimens derived from the human body (blood, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Screening, diagnosis, prognosis, monitoring, or treatment guidance.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. The BlueLEX LD-105's intended use falls outside of this scope.
N/A
Intended Use / Indications for Use
The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.
Product codes
EBZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.
Public Health Service
MAY 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Monitex Industrial Company Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K051203
Trade/Device Name: BlueLEX LD-105 Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 3, 2005 Received: May 11, 2005
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have to reveal your 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 merslate conments, or to devices that have been reclassified in accordance with the provisions of Ameliuments, or to de research Act (Act) that do not require approval of a premarket the rederal I vou, Drag, and Commay, therefore, market the device, subject to the general approvin upprication (1) ... The general controls provisions of the Act include controls provisions of the eightration, 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 IT your device is classified (500 as additional controls. Existing major regulations affecting (1 MA), it may of subject to back and regulations, Title 21, Parts 800 to 898. In your device can or round in the bear in the bear ing your device in the Federal Register.
1
Page 2 - Mr. Mouser
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DT 3 lesalites on that your device complies with other requirements mean that I DA mas made a wees and regulations administered by other Federal agencies. of the Act of ally I ederal statutes and equirements, including, but not limited to: registration 1 ou must comply with an the Hevelong (21 CFR Part 801); good manufacturing practice allu listing (21 CF K Furt 607), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of oversions (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) This letter will anow you to objal finding of substantial equivalence of your device to a premits in the around - The PDF 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), If you desire specific at no for your ce 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dribber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
2
Indication for Use
510(K) Number (if known):
Device Name: BlueLEX LD-105
Indication For Use:
The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.
Prescription Use \u2713 AND / OR Over-The-Counter Use __
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
1 ୧
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Supa Runoo
(Division Sign-Off) Division of Anesthes Infection Control, D.
510(k) Number: