(388 days)
K113655, K 043498
NO REFERENCE DEVICE TEXT PROVIDED
No
The description focuses on the mechanical and optical features of a dental turbine, with no mention of AI or ML.
No.
The document describes a dental turbine family used for mechanical procedures on teeth, such as cavity preparation and material removal, which are not therapeutic in nature. The predicate devices are also identified as turbines, not therapeutic devices.
No
This device is a high-speed dental handpiece used for preparing cavities, removing carious material, removing fillings, and processing tooth and restoration surfaces. It is a treatment device, not a diagnostic one, as it does not gather information about a patient's condition to identify a disease or condition.
No
The device description clearly states that the device is an air-powered, high-speed handpiece, which is a physical hardware component used in dentistry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "high speed handpiece" used for mechanical procedures on teeth, such as preparing cavities, removing material, and processing surfaces. It operates directly on the tooth structure.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is purely mechanical and performed directly in the oral cavity.
Therefore, the Sirona Dental Systems T1 / T2 / T3 turbine family falls under the category of a dental instrument used for direct treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nakanishi Ti-Max X Turbine (K113655), Morita Twin Power Turbine (K 043498)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.
0
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: 49 6251 16 32 94
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
1
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
2
| | Sirona T1 / T2 / T3
turbine family | Nakanishi Ti-Max X
(K113655) | Morita Twin Power
(K043498) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Principle of operation | Turbine
Air driven ¹ | Turbine
Air driven | Turbine
Air driven |
| Couplings to treatment
chair | Sirona, Kavo, NSK,
W&H | Sirona, Kavo, NSK,
W&H, Bienair | Sirona, Kavo, NSK,
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
cavities and crowns
- Removal of carious
material - Removal of fillings
- Processing of tooth
and restoration
surfaces - Reducing hard tooth
structure | ... intended for
removing carious
material, reducing
hard tooth structure,
cavity preparation,
finishing tooth
preparations and
restorations and
polishing teeth. | TWIN POWER
TUBINE is for use by
authorized persons in
the practice of the
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
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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