(53 days)
No
The description focuses on standard LED technology, physical design, and power management, with no mention of AI or ML capabilities.
No
The device is used to activate dental restorative resins, which is a functional process rather than a direct therapeutic treatment for a disease or condition. It facilitates a dental procedure.
No
The device is a light activation system for dental restorative resins, used for curing materials, not for diagnosing conditions or diseases. While it has a radiometer display to verify light output, this is for function verification, not diagnostic purposes.
No
The device description explicitly details physical hardware components such as an LED curing light, light guides, a charging stand, a radiometer display, and lithium-ion batteries. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a light activation system for dental restorative resins." This describes a device used on a patient (or materials being applied to a patient) to cure dental materials.
- Device Description: The description focuses on the physical characteristics, light output, curing times, and accessories related to its function in a dental procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not perform any such analysis of biological specimens.
The Avante LED curing light is a therapeutic device used in a clinical setting, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Avante LED curing light is used as a light activation system for dental restorative resins.
Product codes
EBZ
Device Description
The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133). Both devices are both used as a light activation system for dental restorative resins.
The physical features of the Avante LED curing light provide the dentist with a compact shape and cordless design to facilitate ease of use while using standard light emitting diode technology for optimum curing functions. The Avante LED curing light provides minimum output of 1.000 MW/cm2 which results in typical curing times of 10 seconds for most composite materials. Peak output is measured at 470nm. Curing time can be set between 1- 40 seconds for greater versatility in individual applications.
Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.
The effective portability of the Avante LED curing light is maintained through use of a charging light which is incorporated into the device stand. Included as well in the charging light is a radiometer display to verify proper light output. Lithium-ion batteries power the device and provide 45 minutes on average between charging times.
A review for safety and effectiveness was performed and found not to have been affected.
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)
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
OCT 2 1 2005
6.0 510(K) SUMMARY
The Avante LED curing light performs the same intended function as its predicate device, Versalux (reference K010133). Both devices are both used as a light activation system for dental restorative resins.
The physical features of the Avante LED curing light provide the dentist with a compact shape and cordless design to facilitate ease of use while using standard light emitting diode technology for optimum curing functions. The Avante LED curing light provides minimum output of 1.000 MW/cm2 which results in typical curing times of 10 seconds for most composite materials. Peak output is measured at 470nm. Curing time can be set between 1- 40 seconds for greater versatility in individual applications.
Accessories include the Avante light guides which are available in four diameters to accommodate dentist preference and use.
The effective portability of the Avante LED curing light is maintained through use of a charging light which is incorporated into the device stand. Included as well in the charging light is a radiometer display to verify proper light output. Lithium-ion batteries power the device and provide 45 minutes on average between charging times.
A review for safety and effectiveness was performed and found not to have been affected.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Public Health Service
OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greg Moreau Quality Systems Pentron Clinical Technologies 68-70 north Plains Industrial Road Wallingford, Connecticut 06492
Re: K052349
Trade/Device Name: AVANTE LED CURING UNIT, MODEL N44 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: II Product Code: EBZ Dated: September 29, 2005 Received: October 3, 2005
Dear Mr. Moreau:
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.
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Page 2 - Mr. Moreau
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. 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), please contact the Office of Compliance 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 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/industry/support/index.html.
Sincerely yours,
Srytie jr. Michael Omid.
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
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5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
DEVICE NAME:
INDICATION FOR USE:
The Avante LED curing light is used as a light activation system for dental restorative resins.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over --The-Counter-Use _______________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
Shoop Stirting (Civision Sign-Off) (Civision Sign-Off)
Division of Anesthesiology, General Hospital, Civision of Ancol, Dental Devices 16522349 510(k) Numbled(k) Submission for Avante LED