(76 days)
Not Found
No
The document describes a mechanical dental handpiece and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as an implant handpiece used for drilling and grinding during dental procedures, not for treating diseases or health conditions.
No
Explanation: The device description states its intended use is for "endodontic treatment, dental implant surgeries and general dentistry" and for "surgery, implantology and general dental applications (drilling, grinding etc.)". These are treatment and general dental procedures, not diagnostic ones.
No
The device description clearly describes physical handpieces with transmission ratios, motors, couplings, and an irrigation system, indicating it is a hardware device.
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 Description: The Sirona Dental Systems Implant Handpieces are described as mechanical handpieces used for surgical and general dental procedures. They are used directly on the patient's teeth and gums, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states procedures like endodontic treatment, dental implant surgeries, and general dentistry, all of which are performed directly on the patient.
Therefore, this device falls under the category of a surgical or dental instrument, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Sirona Dental Systems Implant Handpieces are intended for use during endodontic treatment, dental implant surgeries and general dentistry. The Sirona indicated for surgery, Contra-angle handpieces are 20:1/80:1 Implant implantology and general dental applications (drilling, grinding etc.).
Indications for Use:
The Sirona Implant 20:1/80:1 Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The Sirona Implant Handpieces are handpieces with transmission ratios of 80:1 and 20:1. They can be driven by torque adjustable electrical motors for surgery treatments and air motors for general dental treatment. The Implant handpieces are attached to their drives via ISO 3964 coupling. A saline irrigation system for surgery treatment is integral to the Implant Handpieces. The head clamp accepts WB instruments complying with ISO 1797-1.
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
W & H WS-75 E/KM Handpieces (K011061)
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
SEP - 6 2005
510(k) Summary for Sirona Dental Systems Implant Handpieces
1. SPONSOR
Sirona Dental Systems GmbH Farbrikstrasse 31 64625 Bensheim Germany
| Contact Person: | Fritz Kolle |
|---|---|
| Regulatory Manager: |
August 26, 2005 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | Implant Handpieces |
|---|---|
| Common/Usual Name: | Dental Handpiece |
| Classification Name: | Dental Handpiece |
PREDICATE DEVICES 3.
W & H WS-75 E/KM Handpieces (K011061)
INTENDED USE 4.
The Sirona Dental Systems Implant Handpieces are intended for use during endodontic treatment, dental implant surgeries and general dentistry. The Sirona indicated for surgery, Contra-angle handpieces are 20:1/80:1 Implant implantology and general dental applications (drilling, grinding etc.).
1
DEVICE DESCRIPTION 5.
The Sirona Implant Handpieces are handpieces with transmission ratios of 80:1 and 20:1. They can be driven by torque adjustable electrical motors for surgery treatments and air motors for general dental treatment. The Implant handpieces are attached to their drives via ISO 3964 coupling. A saline irrigation system for surgery treatment is integral to the Implant Handpieces. The head clamp accepts WB instruments complying with ISO 1797-1.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The overall design of the Sirona Implant Handpieces is similar to the design of the W & H WS-75 E/KM handpiece in that all of these devices allow the use of instruments complying with ISO 1797-1, the connection to motor via the standardized ISO 3964 coupling and offer a similar saline irrigation system.
Based on the comparison of intended use and technical features, Sirona Dental Systems believes that the Sirona Implant Handpieces are substantially equivalent to the predicate W & H Handpiece. The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
SEP -6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GMBH C/O Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain St. North Attleboro, Massachusetts 02760-4153
Re: K051661
Trade/Device Name: Implant Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EKX Dated: June 21, 2005 Received: June 22, 2005
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Scellon 310(t) profile is substantially equivalent (for the referenced above and have determined the active marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed previe indications for use stated in the chologic, to regardent date of the Medical Device interstate commerce prior to way 20, 1770, the children with the provisions of Amendments, or to devices that have been results approval of a premaint the Federal Food, Drug, and Cosmene Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, subject to the general approval application (1 MA). Tou me), not controls provisions of the Act include controls provisions of the Act. "The gentiral of devices, good manufacturing practice, requirements for unnual regginst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into controls. Existing major regulations affecting.
(PMA), it may be subject to such additional controls. Title 21, Roys 800 to 89 (PMA), it may be subject to such additional controls. Thisons, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title All, The Fed your device can be found in the Code of Peacha. Acguines in the Federal Register.
3
Page 2 -- McNamara-Cullinane
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S issuance of a substantes with other requirements mean that FDA nas made a decemmandin hat your and mistered by other Federal agencies.
of the Act or any Federal statutes and regulations administration to: perstreation of the Act or any rederal statutes and regulations, but not limited to: registration
You must comply with all the Act's requirements and manufacturing progrises You must comply with an the Act 3 Toq (21 CFR Part 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device of your device to a I his letter will anow you to begin maliceming your device of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, and premarket notification. The PDA initing of stockannal vial vice 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), ff you desire specific advice for your device on our our seating on and the regulation please contact the Office of Comphanes at (210) = 10 = 10 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 entified, "Misbranding by reference to premation on your responsibilities under the Act from the may obtain other gelleral mionnation on your i specifical and Consumer Assistance at its toll-free Division of Siman Manataccassel 1, 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K051661
Device Name: Sirona Dental Systems Implant Handpieces
Indications for Use:
The Sirona Implant 20:1/80:1 Contra-angle handpieces are indicated for surgery, implantology and general dental applications (drilling, grinding etc.).
Prescription Use __ X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sumon Kumar
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Sirona Dental Systems Additional Information – K051661 August 26, 2005