(157 days)
No
The summary describes a standard dental unit and chair with no mention of AI or ML capabilities. The device's function is to supply power and serve as a base for other dental devices.
No
The device is described as a base and power supply for other dental devices, not as a device that delivers therapy itself.
No
The device description indicates it is intended to supply power to and serve as a base for other dental devices and accessories. It does not perform diagnostic functions.
No
The device description explicitly lists hardware components such as a connection box, assistant holder, foot control, telescopic tray arm, instrument tray, and operating light.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for supplying power to and serving as a base for dental devices and accessories in a dental clinic/office environment. This is a functional support role for dental procedures, not a diagnostic test performed on samples taken from the body.
- Device Description: The description reinforces the intended use and lists components like a connection box, assistant holder, foot control, etc., which are all related to the physical setup and operation of a dental unit, not diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a piece of dental equipment that facilitates dental procedures, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Product codes
ELA, EIA
Device Description
The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.
The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.
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 clinic/office environment and used by trained dentists and/or dental technicians and assistants.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.
ISO7494-1: 2004, Dentistry - Dental units - Part 1: General requirements and test methods.
ISO7494-2: 2003, Dentistry - Dental units - Part 2: Water and air supply.
ISO 6875: 1995, Dental patient chair.
ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
After performing non-clinical performance studies, the data shows that the proposed device Substantially Equivalent (SE) to the predicate device.
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
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
Exhibit #9 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number:
-
Date of Submission: January 25, 2013 1.
JUL 26. 2013 -
- Sponsor
Xianyang North West Medical Instrument (Group) Co., Ltd No.3, Biyuan Road, Xianyang, Shaanxi, 712000, China
- Sponsor
Establishment Registration Number: 3007031016
Contact Person: Hongmei, Shangguan Position: Quality Engineer Tel: 86 29 33286870 Fax: 86 29 33212053 Email: xyshangguanhongmei@126.com
- Submission Correspondent 3. Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
-
- Proposed Device Identification
Proposed Device Name: Dental Unit with Chair Proposed Device Model: S2310 Device Common Name: operative dental unit
Classification: I Product Code: ELA Regulation Number: 21 CFR 872.6640 Review Panel: Dental
Ed-I
1
Intended Use Statement:
The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
-
- Predicate Device Identification
510(k) Number: K080438 Product Name: Dental Unit with Chair Manufacturer: North West Medical Instrument (Group) Co., Ltd
- Predicate Device Identification
-
Device Description 6.
The proposed device Dental Unit with Chair S2310 is a well equipped with two hands operation dental unit, which is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The proposed device is modification device to Dental Unit with Chair S2318 (K080438). It and the existed device share the same intended use, similar configuration, safety and performance.
The proposed device consists of connection box, assistant holder, foot control, telescopic tray arm, instrument tray and operating light.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility -Requirements and Tests.
ISO7494-1: 2004, Dentistry - Dental units - Part 1: General requirements and test methods.
ISO7494-2: 2003, Dentistry - Dental units - Part 2: Water and air supply.
ISO 6875: 1995, Dental patient chair.
ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
After performing non-clinical performance studies, the data shows that the proposed device E9-2
2
Substantially Equivalent (SE) to the predicate device.
Substantially Equivalent Comparison and Conclusion 8.
Table III-1 Substantially Equivalent Comparison
| ITEM | Proposed Device
Dental Unit with Chair S2310 | Predicate Device
Dental Unit with Chair S2318 (K080438) | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EIA | EIA | |
| Regulation No. | 21 CFR 872.6640 | 21 CFR 872.6640 | |
| Class | I | I | |
| Intended Use | The Dental Unit with Chair is intended to
supply power to and serve as a base for dental
devices and accessories. It is intended for use
in the dental clinic/office environment and
used by trained dentists and/or dental
technicians and assistants. This product is
attached with a dental chair. | The Dental Unit with Chair is intended to
supply power to and serve as a base for
dental devices and accessories. It is intended
for use in the dental clinic/office
environment and used by trained dentists
and/or dental technicians and assistants. This
product is attached with a dental chair. | |
| Power Supply | 110V | 110V | |
| Frequency | 50/60Hz | 50/60Hz | |
| Power (with dental chair) | 400VA | 600VA | |
| Operating
Light | Power Supply | AC12V / 5W | AC 12V / 50W |
| | Illumination | ≤20000lx | Weak: ≤8000lx
Intense: ≥15000lx |
| Pressure of Water Supply | 0.2MPa-0.4MPa | 0.2MPa-0.4MPa | |
| Air Supply Pressure | 0.6MPa-0.8MPa | 0.6MPa-0.8MPa | |
| Dental
Chair | Loading Capacity | 200kg | 135kg |
| | Movement Range
(Chair) | 390mm-740mm | 410mm-750mm |
| | Movement Range
(Backrest) | 1°-70° | 0°-70° |
| | Movement Range
(Headrest) | 150mm | 150mm |
| | Accessories can be attached to
the device | High Speed Handpiece / Fiber Optic
Handpiece/ Low Speed Handpiece / Scaler /
Curing Light / Dental Chair /
Three-way-Syringe | High Speed Handpiece / Fiber Optic
Handpiece/ Low Speed Handpiece / Scaler /
Curing Light / Dental Chair /
Three-way-Syringe |
| | Operation Method | Control Panel / Assistant Control Panel / Foot
Controller | Control Panel / Assistant Control Panel /
Foot Controller |
Difference in Power (with dental chair), Illumination, and Dental Chair between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
3
The proposed device, Dental Unit with Chair S2310, is determined to be Substantially Equivalent (SE) to the predicate device, Dental Unit with Chair (K080438), in respect of safety and effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G601 Silver Spring, MD 20993-0002
July 26, 2013
Xianyang North West Medical Instrument (Group) Company, Limited C/O Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, China 200237
Re: K130410
Trade/Device Name: Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 25, 2013 Received: June 28, 2013
Dear Ms. Hong:
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.
5
Page 2 - Ms. Hong
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 devicerelated 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/8 description: The image shows the name "Mary S. Bunner -S" in a bold, sans-serif font. The letters "Mary" and "-S" are in a solid black color, while the letters "S. Bunner" appear to be filled with a pattern of smaller letters or symbols, giving them a textured look. The text is horizontally oriented and appears to be a title or heading.
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Premarket Notification 510(k) Submission
Section II Indications for Use
510(k) Number: K130410
Device Name: Dental Unit with Chair
Indications for Use:
The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinicoffice environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
Mary S. Runner -S
Susan Runnn DOS, MA 2013.07.26
10:50:57-04'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K130410
:
.
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