(78 days)
Not Found
No
The device description and performance studies focus on mechanical and sterilization aspects, with no mention of AI or ML.
No
The device is used to prepare dental cavities for restoration, which is a procedural step rather than a therapeutic treatment itself.
No
The device is described as a high-speed dental handpiece used for preparing dental cavities for restorations, which is a therapeutic intervention, not a diagnostic one. There is no mention of it being used to detect or diagnose conditions.
No
The device description clearly states it is an air-powered, high-speed handpiece constructed of titanium with physical components like a fiber optic rod, spray nozzles, and retraction valves. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Siemens T1 CONTROL high speed dental handpiece is a tool used directly on the patient's teeth to prepare cavities. It is a mechanical device for physical manipulation, not for analyzing biological samples.
- Intended Use: The intended use clearly states "to prepare dental cavities for restorations, such as fillings," which is a direct dental procedure, not an in vitro test.
The description focuses on the physical characteristics, operation, and sterilization of the handpiece, all of which are consistent with a surgical or procedural tool, not an IVD.
N/A
Intended Use / Indications for Use
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings.
Product codes
76 EFB
Device Description
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings. The device is an air-powered, high speed handpiece constructed of titanium. The device is reusable, is ergonomically shaped, and includes a solid fibre optic rod built-in light system. The water delivery geometry includes three spray nozzles in the device head with one-way retraction valves to prevent the ingress of external air or liquid when the spray system is shut down. The device can be sterilized by the steam autoclave method.
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
dental operatory
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 Siemens T1 CONTROL Dental Handpiece complies with ISO Standard 7785-1 for High Speed Air Turbine Handpieces, ISO Standard 1797 for Dental Rotary Instruments - Shanks, and ISO Standard 9168 for Dental Handpieces - Hose Connectors. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness.
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
§ 872.4200 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
K965238
MAR 1 9 1997
510(k) SUMMARY SIEMENS AG T1 CONTROL HIGH-SPEED DENTAL HANDPIECE
DATE PREPARED 1.
December 30, 1996
2. SUBMITTER
Siemens AG Medical Technology Dental Systems Fabrikstrasse 31 64625 Bensheim Germany
CONTACT 3.
Mr. Hermann Landgraf コース | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 011-49-62-51-16-2359
4. DEVICE NAME
| Proprietary Name: | T1 CONTROL High Speed Dental Handpiece |
|---|---|
| Common/Usual Name: | Dental Handpiece |
| Classification Name: | Air-powered Dental Handpiece |
1
ડ. DEVICE CLASSIFICATION
Air-powered dental handpieces and accessories have been classified under Section 513 of the Act as Class I devices by the Dental Devices Panel.
Classification Regulation: 21 CFR 872.4200 Product Code: 76 EFB
ર્. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS
The Siemens T1 CONTROL high speed dental handpiece is intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings. The device is an air-powered, high speed handpiece constructed of titanium. The device is reusable, is ergonomically shaped, and includes a solid fibre optic rod built-in light system. The water delivery geometry includes three spray nozzles in the device head with one-way retraction valves to prevent the ingress of external air or liquid when the spray system is shut down. The device can be sterilized by the steam autoclave method.
The Siemens T1 CONTROL high-speed dental handpiece is similar in design, function, and intended use to other high-speed dental handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the Tradition high-speed handpiece manufactured by Midwest (K863677), the Star Dental 430 series high-speed handpiece manufactured by DEN-TAL-EZ. Inc. (K960719), and the W&H 898 Top Light high-speed handpiece manufactured by A-DEC, Inc. (K944710).
7. PERFORMANCE TESTING
The Siemens T1 CONTROL Dental Handpiece complies with ISO Standard 7785-1 for High Speed Air Turbine Handpieces, ISO Standard 1797 for Dental Rotary Instruments - Shanks, and ISO Standard 9168 for Dental Handpieces - Hose Connectors. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness.
Siemens AG 510(k) T1 Dental Handpiece
3/18/97