ELECTRIC HANDPIECE SYSTEM

K132570 · Ttbio Corp. · EBW · Apr 29, 2014 · Dental

Device Facts

• Record ID: K132570
• Device Name: ELECTRIC HANDPIECE SYSTEM
• Applicant: Ttbio Corp.
• Product Code: EBW · Dental
• Decision Date: Apr 29, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

Device Story

Thor 700 Electric Handpiece System; converts pneumatic output from dental treatment unit into electrical energy; powers motorized dental handpieces. System includes system unit, power supply, control tube, dental drive device (micromotor). Inputs supplied by dental treatment unit; speed controlled via treatment unit foot pedal. Provides digital speed readout; features forward/reverse switches; two programmable settings. Used in dental clinics by licensed professionals. Benefits include precise control of handpiece torque, speed, and rotation for dental procedures.

Clinical Evidence

No clinical data. Bench testing only. Electromagnetic compatibility and electrical safety tested per IEC 60601-1-2 and IEC 60601-1. Performance testing conducted per ISO 11498. Sterilization validated per ANSI/AAMI ST79:2010 (132°C for 15 minutes). Biocompatibility testing per ISO 10993-10 showed negligible response.

Technological Characteristics

Materials: Aluminum, stainless steel, plastic. Energy: Pneumatic input converted to electrical output (48V DC). Dimensions: 22mm motor diameter. Connectivity: External installation to dental treatment center. Standards: ISO-3964 (coupling), ISO-9168 (hose connections), ISO-11498 (noise). Sterilization: Autoclave (132°C). Software: Validated per FDA guidance.

Indications for Use

Indicated for use by licensed dental professionals to convert pneumatic output from a dental treatment center into electrical energy to power electrically-driven dental handpieces.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Siro Torque L (K031584)

Submission Summary (Full Text)

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K132570

APR 2 9 2014

Image /page/0/Picture/2 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters followed by the word "BIO". The "T" letters are bold and angled, with the first "T" being solid black and the second "T" having a textured appearance. The word "BIO" is outlined, with the letters "B" and "O" having distinct shapes.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 FAX : [phone] TEL : [phone] E-mail: [e-mail] http://www.ttbio.com

# 510(K) SUMMARY Electric Handpiece System

- 1. Date Summary Prepared: March 25,2014
- 2. Submitter Information
- 510(k) Owner: TTBIO CORP.

2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Jo S.C. Lee/QA Engineer Phone: [phone]/e-mail: [e-mail]

#### 3. Device Name

Trade Name: Thor 700 Electric Handpiece System Common Name: Dental Handpiece and Accessories Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200, Product Code EBW)

- 4. Predicate Device: Siro Torque L, (K031584)
- 5. Device Description:

Thor 700 Electric Handpiece System is composed of a system unit, which is connected to a : power supply and a control tube, that system unit drives a dental drive device. The system unit converts pneumatic output from the dental treatment unit to control the torque, speed and directional rotation of the dental drive device. The dental drive device, in turn, provides the control for motorized dental handpieces. The inputs to the system unit are supplied by a dental treatment unit. Inputs can also be controlled by the foot pedal of the treatment unit.

- 6. Intended Use:
Thor 700 Electric Hnadpiece system is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

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Image /page/1/Picture/0 description: The image shows the logo for TT BIO. The logo consists of two stylized, bold, black "T"s followed by the word "BIO" in a thin, outlined font. The "T"s are angled and slightly overlapping, creating a modern and dynamic look. The word "BIO" is positioned to the right of the "T"s, completing the logo.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : [phone] FAX : [phone] E-mail: [e-mail] http://www.ttbio.com

7. Substantial Equivalency:

| Substantial Equivalence Table | | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Descriptive Information | Device<br>(Thor 700) | Predicate devices (Siro Torque<br>L; K031584) |
| | | |
| Intended for Use | Thor 700 is intended to convert<br>pneumatic output from a dental<br>treatment center to electrical<br>energy for operation of<br>electrically-driven dental<br>handpieces. | The Siro Torque L is intended to<br>convert pneumatic output from a<br>dental treatment center to<br>electrical energy for operation of<br>electrically-driven dental<br>handpieces. |
| Components | System unit, power supply,<br>control tube and a dental drive<br>device (micromotor). | Control unit, power supply, hose<br>and two alternative electric<br>micromotors. |
| Principle of operation | External power was supplied to<br>Thor 700 through a power<br>supply. Cooling water and<br>cooling air are supplied by the<br>dental treatment center and the<br>foot padel controls the dental<br>drive device speed. | External power was supplied to<br>Siro Torque L through a power<br>supply. Cooling water and<br>cooling air are supplied by the<br>dental treatment center and the<br>foot padel controls the<br>micromotor speed. |
| Composition of Materials | Aluminum, Stainless Steel,<br>Plastic | Aluminum, Stainless Steel,<br>Plastic |
| The patient-contacting<br>portions of the device | No contact with patients | No contact with patients |
| System unit | Yes | Yes |
| Speed Control | Yes | Yes |
| Digital speed readout | Yes | Yes |
| Installation capability | external | internal/external |
| Individually<br>programmable settings | 2 | 2 |
| Forward/reverse switches | Yes | Yes |
| Spray water pressure | 36 psi (2.5bar) | 29 psi (2.0 bar) |
| Spray air pressure | 29 psi (2.0bar) | 39 psi (2.7 bar) |
| Power supply | | |
| Voltage input | AC : 100 - 240 V AC<br>50/60 Hz | AC : 100-240 V AC<br>50/60 Hz |
| Voltage output | DC : 48V DC | DC : 24V DC |
| Dental drive device | | |
| Motor speed | 2000 ~ 40000 rpm | 2000 ~ 40000 rpm |
| Motor diameter | 22 mm | 21 mm |
| torque | 3 N-cm maximum | 2.4 N-cm maximum |
| weight | 62 grams | 100 grams |
| Substantial Equivalence Table | | |
| Descriptive Information | Device<br>(Thor 700) | Predicate devices (SiroTorque<br>L; K031584) |
| Technical Specification | | |
| Cooling air pressure | 30 NL/min | 30 NL/min |
| Spray air pressure | 36 psi (2.5bar) | 39 psi (2.7bar) |
| Spray water pressure | 29 psi (2.0bar) | 29 psi (2.0bar) |
| Torque | max. 3.0 N-cm | max. 2,4 N-cm |
| Speed range | 2000~40000 rpm | 2000~40000 rpm |
| Coupling dimensions | According to ISO-3964 | According to ISO-3964 |
| Hose connections | According to ISO-9168 | According to ISO-9168 |
| Noise | According to ISO-11498 | According to ISO-11498 |

-

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TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : [phone] FAX : [phone] E-mail: [e-mail] http://www.ttbio.com

Thor 700 Electric Handpiece System is substantially equivalence to the Siro Torque L (K031584) on equivalence intended uses and technical characteristics.

- 8. Discussion of non-clinical data:
Testing of electromagnetic compatibility and electrical safety has been conducted in accordance with IEC 60601-1-2 and IEC 60601-1. The software has been successfully validated to confirm the performance of Thor 700 Electric handpiece System according to the FDA guidance-" General principle of Software Validation; Final Guidance for Industry and FDA staff", dated January 11, 2002.

The performance testing was conducted according to ISO 11498 and sterilization validation 132℃ for 15 minutes, drying time for 30 minutes was performed in accordance to ANSI/AAMI ST79:2010.

Biocompatibility testing was conducted according to ISO 10993-10 and the results showed that No erythema and no oedema were observed on the skin of the rabbits. The response of the test article was categorized as "negligible".

- 9. Discussion of Clinical Tests Performed:
N/A

## 10. Conclusion:

The above descriptions coincide with the substantial equivalence, Siro Torque L (K031584). They are substantial equivalent to the predicate device in terms of its intended use, operating principles and functions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G60 Silver Spring, MI) 20993-0002

### April 29, 2014

TTBIO CORPORATION Shu-Ching Lee Engineer 2F, No.7, 6th Road Industry Park Taichung. Taiwan R.O.C 40755

Re: K132570

Trade/Device Name: Electric Handpiece System, Model Thor 700 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: March 25. 2014 Received: March 27, 2014

Dear Mr. Lee:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Page 2 - Mr. Lee

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Russo, DDS, MA

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T"s followed by the word "BIO". The "T"s are blocky and angled, with a three-dimensional effect. The word "BIO" is written in a simple, sans-serif font.

TTBIO CORP. 2F, NO.7, 6" ROAD INDUSTRY PARK, AICHUNG, TAIWAN, R.O.C. 40755 FAX : [phone] -mail: [e-mail] http://www.ttbic

# Indications for Use

510(K) Number (If Known): Device Name: Electric Handpiece System, Model Thor 700. Indications for Use:

Thor 700 Electric Handpiece System is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpiece.

CAUTION: Federal (US)) law restricts the use of this device to licensed professionals

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

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Sheena 2014.04