(28 days)
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No
The 510(k) summary describes a standard dental curing light and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is used for curing dental materials, not for treating diseases or conditions.
No
The device is a curing light used for restorative materials, not for diagnosing conditions or diseases.
No
The intended use describes a "Curing Light," which is a hardware device used in dentistry. There is no mention of software as the primary or sole component.
Based on the provided information, the AirDent "Radiance" Curing Light is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for curing dental materials within the patient's mouth (restoration of cavity preparation, curing of bonding and other photo-curing restorative materials). This is an in vivo application, meaning it's used on a living organism.
- Definition of IVD: 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. The AirDent "Radiance" Curing Light does not perform any such tests on biological samples.
Therefore, the AirDent "Radiance" Curing Light is a dental device used for treatment and restoration in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AirDent "Radiance" Curing Light is indicated for use in curing dental composite resin materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used.
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with wavy lines below them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 24 1998
Mr. Joseph Carey Director of Quality Assurance Air Techniques, Incorporated 70 Cantiaque Rock Road P.O. Box 870 Hicksville, New York 11801
Re : K982615 AirDent "Radiance" Curing Light Trade Name: Requlatory Class: II Product Code: EBZ Dated: July 22, 1998 Received: July 27, 1998
Dear Mr. Carey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Mr. Carey
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page of
| 510(k) Number (if known): | K982615 |
|---|---|
| Device Name: | AirDent "RADIANCE" Curing Light |
Indications For Use:
The AirDent "Radiance" Curing Light is indicated for use in curing dental composite resin materials for restoration of cavity preparation, curing of bonding and other photo-curing restorative materials as well as any application where a conventional dental curing light would be used.
(PLEASE DO NOT WILTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDBOD
Concurence of CDRH, Office of Device Evaluation (ODE)
Suan Russey
(Division Sign Ciri Division of Dental, Infortes, Control, and General Hospital De ين يوت ૮૫૪ 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
8661/6Z/L0
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