T1/T2/T3 TURBINE FAMILY

K131319 · Sirona Dental Systems GmbH · EFB · May 30, 2014 · Dental

Device Facts

• Record ID: K131319
• Device Name: T1/T2/T3 TURBINE FAMILY
• Applicant: Sirona Dental Systems GmbH
• Product Code: EFB · Dental
• Decision Date: May 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The turbines of the T1 / T2 / T3 Turbine family are intended for the - Preparation of cavities and crowns - Removal of carious material - Removal of fillings - Processing of tooth and restoration surfaces - Reducing hard tooth structure

Device Story

Sirona T1/T2/T3 Turbine family consists of reusable, air-powered, high-speed dental handpieces. Devices feature ergonomic designs; T1 and T2 models include fiber optic lighting. Water delivery system utilizes 4 pairs of water/air spray nozzles with one-way retraction valves to prevent ingress of external contaminants. Handpieces are compatible with various quick-couplings (Sirona, KaVo, W&H, NSK). Operated by dentists in clinical settings to perform cavity/crown preparation, caries/filling removal, and tooth structure reduction. Sterilizable via autoclave. Output is mechanical rotation of dental burs for tooth/restoration processing; light output assists visualization. Benefits include efficient removal of tooth structure and restoration materials during dental procedures.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 14457 (handpieces/motors), ISO 1797 (rotary instruments), ISO 9168 (hose connections), and ISO 21531 (graphical symbols) was demonstrated. Additional testing validated sterilization processes, device effectiveness, and biocompatibility.

Technological Characteristics

Air-powered turbine handpieces; materials include metal components; push-button FG chuck; fiber optic light (25,000 lux on T1/T2); speed range 250,000-400,000 rpm; power 20-23W. Compatible with Sirona, KaVo, W&H, and NSK quick-couplings. Sterilization via autoclave. Standards: ISO 14457, ISO 1797, ISO 9168, ISO 21531.

Indications for Use

Indicated for dental procedures including cavity and crown preparation, removal of carious material and fillings, processing of tooth and restoration surfaces, and reduction of hard tooth structure in patients requiring dental restorative work.

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

• Nakanishi Ti-Max X Turbine (K113655)
• Morita Twin Power Turbine (K043498)

Submission Summary (Full Text)

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## 510(k) Summary

## MAY 3 0 2014

### for

## Sirona Dental Systems T1 / T2 / T3 Turbine family

### with serial no. > 600 000

#### Sponsor 1

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany

Contact Person: Fritz Kolle Telephone: [phone]

Date Prepared: May 1, 2013

#### ମଧ Device Name

Proprietary Name: T1 / T2 / T3 Turbine family with serial no. > 600 000

Common/Usual Name: High speed air turbine

Classification Name: Handpiece, air-powered, dental

#### 3 Predicate Devices

Nakanishi Ti-Max X Turbine (K113655) and the Morita Twin Power Turbine (K 043498)

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

APPENDIX G . Page 1 of 3

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#### 4 Intended Use

The turbines of the T1 / T2 / T3 Turbine family are intended for the

- Preparation of cavities and crowns
- Removal of carious material
- Removal of fillings
- Processing of tooth and restoration surfaces
- Reducing hard tooth structure

#### Device Description 4.1

The Sirona Dental Systems T1 / T2 / T3 turbine family consists of air powered, high speed handpieces. The handpieces are reusable, ergonomically shaped and include (T1 and T2 Turbines) a fiber optic light system. The water delivery geometry includes 4 pair of water / air spray nozzles just below the head with one way retraction valves to prevent the ingress of external water or air, when the spray system is shut down. The devices are sterilizable in an autoclave. The turbines are provided in three variants: control, boost and mini.

In addition, the turbines are compatible with the following quick-coupling:

- Sirona R coupling
- Sirona F coupling
- Sirona B coupling
- KaVo coupling
- W&H coupling
- NSK MachLite coupling
- NSK QD-J coupling

#### 5 Summary of the technological characteristics

The Sirona Dental Systems T1 / T2 / T3 turbine familar in the operating principle, technical data and performance to other high speed dental handpieces currently in the US commercial distribution. Examples of substantially equivalent devices include Nakanishi Ti-Max X Turbine (K113655) and the Morita Twin Power Turbine (K 043498). Below is a comparison of the proposed device to the predicate devices.

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

APPENDIX G . Page 2 of 3

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| | Sirona T1 / T2 / T3<br>turbine family | Nakanishi Ti-Max X<br>(K113655) | Morita Twin Power<br>(K043498) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Principle of operation | Turbine<br>Air driven ¹ | Turbine<br>Air driven | Turbine<br>Air driven |
| Couplings to treatment<br>chair | Sirona, Kavo, NSK,<br>W&H | Sirona, Kavo, NSK,<br>W&H, Bienair | Sirona, Kavo, NSK,<br>W&H, Morita |
| Speed range | 250000-400000 | 300000-450000 | 320000-400000 |
| Power [W] | 22/ 23/ 20 | 16-22 | 18 -22 |
| Chuck | Push button FG | Push button FG | Push button FG |
| Light intensity [lux] | 25000 | Data not available | 25000 |
| Intended use | - Preparation of<br>cavities and crowns<br>- Removal of carious<br>material<br>- Removal of fillings<br>- Processing of tooth<br>and restoration<br>surfaces<br>- Reducing hard tooth<br>structure | ... intended for<br>removing carious<br>material, reducing<br>hard tooth structure,<br>cavity preparation,<br>finishing tooth<br>preparations and<br>restorations and<br>polishing teeth. | TWIN POWER<br>TUBINE is for use by<br>authorized persons in<br>the practice of the<br>dentistry |

| | | | | | Table 1: Comparison of the proposed device to the declared predicate devices. |
|--|--|--|--|--|-------------------------------------------------------------------------------|
| | | | | | |

1 As described in Sec. 11.1 ion page 9 and 10 in the original submission

#### 6 Performance Testing

The Sirona T1 / T2 /T3 turbine family complies with ISO 14457 Dentistry -Handpieces and motors, ISO 1797 Dental Rotary Instruments - Shanks, ISO 9168 Dental Handpieces - Hose Connections, ISO 21531 Dentistry - Graphical symbols for dental instruments, additional performance testing was conducted to validate the sterilization process, device effectiveness and biocompatibility. Reverse engineering of the quick coupling was also conducted.

#### 7 Clinical Testing

Clinical testing has not been performed.

#### 8 Conclusion

Based on a comparison of intended use, indications, principal of operations, features and technical data, the Sirona Dental T1 / T2 / T3 high speed turbine family is substantially equivalent to its Predicate Devices.

Sirona Dental Systems T1 / T2 / T3 Turbine family with serial no. > 600 000 Traditional 510(k) Summary May 1, 2013

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract symbol that resembles a person with outstretched arms. The symbol is made up of three curved lines.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug, Administration 19903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### May 30, 2014

Sirona Dental Systems GmbH Mr. Fritz Kolle Regulatory Manager Fabrikstrasse 31 Bensheim. Germany D-64625

Re: K131319

Trade/Device Name: TI/T2/T3 Turbine family with serial n. > 600,000 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 25, 2014 Received: April 28, 2014

Dear Mr. Kolle:

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 Cosmelic 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.

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Page 2 - Mr. Kolle

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); 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Mary S. Runner -S

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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#### INDICATIONS FOR USE STATEMENT 4

Indications for use

510(k) Number (if known): K131319

Device Name: T1 / T2 / T3 Turbine family with scrial n. > 600 000, Models:

TI CONTROL S ;TI CONTROL K; TI CONTROL W; TI CONTROL N; TI Boost S; TI Boost K; T1 Boost W; T1 Boost N; T1 mini K; T1 mini K; T1 mini N; T1 mini N; T2 CONTROL S; 12 CONTROL K; T2 CONTROL W; T2 CONTROL N; T2 Boost S; T2 Boost K; T2 Boost W; T2 Boost N; T2 mini S; T2 mini W; T2 mini N; T2 Boost S; T3 Boost K; T3 Boost W: T3 Boost NO: T3 mini S; T3 mini K; T3 mini W; T3 mini NQ;

Indications for Use:

The turbines of the T1 / T2 / T3 Turbine family are intended for the

- Preparation of cavities and crowns
- Removal of carious material
- Removal of fillings
- Processing of tooth and restoration surfaces
- Reducing hard tooth structure

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Andrew I. Steen -S 2014.05.30 08:48:08 -04'00'

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Sirona Dental Systems traditional 510(k) May 1, 2013 T1 / T2 / T3 Turbine family

CONFIDENTIAL Page 3