(236 days)
Not Found
No
The summary describes a dental curing light with variable time and wavelength settings, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is used for polymerizing restorative materials, which is a functional process rather than a therapeutic treatment of a disease or condition.
No
The device is a dental curing light used to polymerize restorative materials, not to diagnose medical conditions.
No
The device description explicitly states it is a "visible-light dental curing device," which is a hardware device that emits light.
Based on the provided information, the Bisco LED device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice." This describes a device used on a patient (or materials being applied to a patient) for a therapeutic or restorative purpose, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a "visible-light dental curing device," which aligns with the intended use of hardening dental materials.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
Therefore, the Bisco LED is a dental device used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bisco LED, a visible-light dental curing device, is intended to provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice.
Bisco LED is a LED dental curing light.
Product codes
EBZ
Device Description
Bisco LED is a dual peak wavelength visible-light dental curing device, with built-in variable time settings allowing for a selection of time and wavelength.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
TRANSCURE, MODEL 2910 (K022862)
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
Section 5 MAR 2 9 2006 510 (k) SUMMARY
| Applicant: | Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Benjamin Lichtenwalner
Tel: 847-534-6146
Fax: 847-534-6111 |
| Date Prepared: | July 20, 2005 |
| Trade Name: | Bisco LED |
| Common Name: | Dental Curing Light |
| Trade Name: | BISCO LED |
|---|---|
| Common Name: | Dental Curing Light |
| Classification/Name: | Activator, Ultraviolet, For Polymerization |
| Class II per 21 CFR 872.6070 |
Description of Applicant Device:
Cl
Bisco LED is a dual peak wavelength visible-light dental curing device, with built-in variable time settings allowing for a selection of time and wavelength.
Intended uses of Applicant Device:
Bisco LED, a visible-light dental curing device, is intended to provide the visible light required for polymerizing photo-initiated restorative materials used in dental practice.
Predicate Devices: TRANSCURE, MODEL 2910 (K022862) dated October 18, 2002.
Significant Performance Characteristics:
Bisco LED to TRANSCURE
| Property | Bisco LED | TRANSCURE |
|---|---|---|
| Intended use | Dental Curing Light | Dental Curing Light |
| Physical Properties | One Battery Powered, Handheld | |
| Unit containing both blue and | ||
| purple LED's | Two Battery Powered, Handheld | |
| Units with one for the blue and | ||
| one for the purple LED's | ||
| Mechanical Properties | Uses LED's to selectively output | |
| either the blue or purple light. |
Side by side comparisons of Bisco LED to the predicate device TRANSCURE clearly demonstrates that the applicant device is substantially equivalent to the legally marketed device.
Page 5-1
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Mr. Benjamin Lichtenwalner Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K052122
Trade/Device Name: Bisco LED Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: II Product Code: EBZ Dated: March 20, 2006 Received: March 21, 2006
Dear Mr. Lichtenwalner:
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. Benjamin Lichtenwalner
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 vours.
Chiu Lin, Ph.D.
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
3
510 (k) Number (if known):
Device Name: Bisco LED
Indications for Use:
Bisco LED is a LED dental curing light.
Prescription Use ✔ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Burns
" Circus General Ho Cial =