(44 days)
No
The description focuses on the device's physical characteristics, light modes, battery, and accessories, with no mention of AI or ML capabilities.
No
The device is an LED curing light used to polymerize dental materials, which is a functional process rather than a therapeutic one directed at treating a disease or condition.
No
This device is an intraoral curing light used to polymerize dental materials, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "LED curing light" with a "compact, lightweight hand piece" and a "rechargeable battery," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "polymerize visible light cure (VLC) dental materials". This is a therapeutic or procedural function performed directly on the patient's oral cavity.
- Device Description: The description details a light-emitting device used for curing materials within the mouth. This aligns with a dental procedure, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The TUTU ™ LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials
Product codes
EBZ
Device Description
The TuTu7 is a LED curing light that is small and easy to use, vet powerful and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. The TuTu has 3 different functioning modes, continuous, pulse and ramp. The device peeps every 3 seconds for precise timing of exposure, regardless of mode setting. The rechargeable battery is a Lithium lon, which at full charge can last up to 120 minutes. The TuTu is provided with a battery charger, which also acts as a storage holder for the device. A silicone sheath is provided to refract the light and protect the eyes of the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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
510(k) Summary Invisible Technology TuTu 7 Dental Curing Light
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).
807 92(a)(1)
Submitter Information
Invisible Technology (IV-Tech) Nassa B/D 4F, 581 Shinsa-Dong Kangnam-ku, Seoul Korea #135-892
- Tae Hee, Cho Contact Person:
- September 12, 2006 Date:
807.92(a)(2)
TuTu 7 Trade Name:
- Common Name: Dental Curing Light
- Classification Name(s): Ultraviolet Activator for Polymerization - 872.6070
- Classification Number: EBZ
807.92(a)(3)
Predicate Device(s)
| Dentsply International | SmartLite PS Pen-Style
LED Curing Light | K041372 |
|------------------------|--------------------------------------------|---------|
| 3M ESPE AG | Elipar FreeLight | K011154 |
1
510(k) Summary Invisible Technology TuTu 7 Dental Curing Light 807.92 (a)(4)
Device Description
The TuTu7 is a LED curing light that is small and easy to use, vet powerful and swift in curing. It has a compact, lightweight hand piece, with a curved and contoured tip, to allow the light to be positioned and applied anywhere in the oral cavity. The TuTu has 3 different functioning modes, continuous, pulse and ramp. The device peeps every 3 seconds for precise timing of exposure, regardless of mode setting. The rechargeable battery is a Lithium lon, which at full charge can last up to 120 minutes. The TuTu is provided with a battery charger, which also acts as a storage holder for the device. A silicone sheath is provided to refract the light and protect the eyes of the operator.
807.92(a)(5)
Intended Use(s)
The TUTU ™ LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials
807.92(a)(6)
| | SmartLite PS LED
Curing Light
DENTSPLY
K041372 | Elipar FreeLight
3M ESPE AG
K011154 | TuTu 7
IV-Tech
This Submission |
|-------------------------|---------------------------------------------------------|-------------------------------------------|--------------------------------------|
| Product Code | EBZ | EBZ | EBZ |
| CFR | 872.6070 | 872.6070 | 872.6070 |
| Wavelength
Range n/m | 450-475 | 430-480 | 380-480 |
| Watts mW-cm | 950 | 1200 | 1300 |
| Battery Type | NMH | NHH | 2,300 Li-on
Battery |
| Weight | 100g | 220g | 142g |
| Rotating Tip | Yes | No | No |
| Built in meter | No | Yes | No |
| Repl. Bulb | No | No | Yes |
| Multiple Curing
Time | No | Yes | Yes |
| LED Blue Light | Yes | Yes | Yes |
Technological Characteristics
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of four curved lines that resemble human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2006
Invisible Technology Company, LTD C/O Ms. Allison Scott The Anson Group 11460 North Meridian Street, Suite 150 Carmel, Indiana 46032
Re: K062735
Trade/Device Name: TuTu 7 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: September 12, 2006 Received: September 13, 2006
Dear Ms. Scott:
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.
3
Page 2 - Ms. Allison Scott
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Susan Runner
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 《O(g L735
Device Name:
- ...
ini
Indications For Use:
The TUTU ™ LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials
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 Punner
on Gign-Off) ion of Anesthesiology, General Hospital, con Control, Dental Devices
Number. K062735
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