TUTU 7, MODEL IV-T22

K062735 · Invisible Technology Co., Ltd. · EBZ · Oct 27, 2006 · Dental

Device Facts

• Record ID: K062735
• Device Name: TUTU 7, MODEL IV-T22
• Applicant: Invisible Technology Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

TuTu 7 is a handheld, battery-operated LED dental curing light used by dental professionals to polymerize light-cure dental materials. The device features a compact, lightweight handpiece with a contoured tip for intraoral positioning. It utilizes a rechargeable Lithium-ion battery and offers three operational modes: continuous, pulse, and ramp. An audible beep occurs every 3 seconds to assist with exposure timing. A silicone sheath is provided to refract light and protect the operator's eyes. The device is supplied with a combination battery charger and storage holder. By emitting blue light, the device initiates the polymerization of dental sealants, adhesives, and restorative materials, facilitating dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

LED-based dental curing light; wavelength range 380-480 nm; power output 1300 mW/cm²; powered by 2,300 mAh Lithium-ion battery; lightweight handpiece (142g); three curing modes (continuous, pulse, ramp); includes battery charger/storage base and silicone eye-protection sheath.

Indications for Use

Indicated for polymerization of visible light cure (VLC) dental materials, including pit and fissure sealants, bonding adhesives, cements, restorative, or luting materials in a dental clinical setting.

Regulatory Classification

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.

Predicate Devices

• SmartLite PS Pen-Style LED Curing Light (K041372)
• Elipar FreeLight (K011154)

Submission Summary (Full Text)

{0}------------------------------------------------

510(k) Summary Invisible Technology TuTu 7 Dental Curing Light

K062735

# 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<br>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<br>Curing Light<br>DENTSPLY<br>K041372 | Elipar FreeLight<br>3M ESPE AG<br>K011154 | TuTu 7<br>IV-Tech<br>This Submission |
|-------------------------|---------------------------------------------------------|-------------------------------------------|--------------------------------------|
| Product Code | EBZ | EBZ | EBZ |
| CFR | 872.6070 | 872.6070 | 872.6070 |
| Wavelength<br>Range n/m | 450-475 | 430-480 | 380-480 |
| Watts mW-cm | 950 | 1200 | 1300 |
| Battery Type | NMH | NHH | 2,300 Li-on<br>Battery |
| Weight | 100g | 220g | 142g |
| Rotating Tip | Yes | No | No |
| Built in meter | No | Yes | No |
| Repl. Bulb | No | No | Yes |
| Multiple Curing<br>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 [phone]. 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 [phone] or [phone] 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

Page 1 of of

16