(45 days)
Not Found
No
The summary describes a standard dental unit and chair with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No.
The device is described as supplying power and serving as a base for other dental devices, not directly treating a medical condition.
No
The device's intended use is to supply power to and serve as a base for other dental devices, not to diagnose a condition.
No
The device description clearly lists multiple hardware components such as a main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, and operating light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to supply power to and serve as a base for dental devices and accessories." It is used in a dental clinic/office environment by dental professionals. This describes a piece of equipment used during dental procedures, not a device used to test samples in vitro (outside of the body) to diagnose conditions.
- Device Description: The components listed (main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light) are all typical components of a dental chair and unit, which are used for patient positioning and providing access to instruments and power during dental treatment. None of these components are associated with laboratory testing or analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
Therefore, the Dental Unit with Chair is a piece of dental equipment used for patient care and supporting dental procedures, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
EIA
Device Description
The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.
All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, 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)
Not Found
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.
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
§ 872.6640 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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
1. Applicant Device Information
Trade/Proprietary Name: Dental Unit with Chair Model: S2300, S2305, S2308, S2315, S2318, S2320 Common Name: Dental Unit with Chair Classification Name: Unit, Operative Dental Device Class: I Product Code: EIA Regulation Number: 872.6640 Review Panel: Dental 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.
2. Submitter Information
Sponsor and Manufacturer:
North West Medical Instrument (Group) Co., Ltd No.3 Biyuan Road, Xianyang, 712000 Shaanxi, China
Contact Person of the Submission:
Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road, 200230 Shanghai, China Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809
1
Email: Diana.hong@mid-link.net
3. Predicate Device
K Number: K032543 C8+DENTAL OPERATIVE UNIT Classification Name: Unit, Operative Dental Product Code: EIA Manufacturer: SIRONA DENTAL SYSTEMS GMBH.
4. Device Description
The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.
All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.
5. Effectiveness and Safety Considerations
Effectiveness:
The Dental Unit with Chair comply with ISO7494-1, ISO7494-2, ISO6875 and ISO9168.
Safety Considerations:
The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility.
The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -. Requirements and tests
2
The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
6. Substantially Equivalence Determination
Comparison Analysis
The applicant device has same classification information, same indications and intended use, similar product design, similar technical specification, biological specification and safety specification. The applicant device doesn't provide the video system, but it is substantially equivalent to the predicate device in other parts.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
North West Medical Instrument (Group) Company, Limited C/O Ms. Laura Danielson Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8NW New Brighton, Minnesota 55112
APR - 4 2008
Re: K080438
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: March 20, 2008 Received: March 21, 2008
Dear Ms. Danielson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Danielson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Quong
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
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Y.Indications for Use
510(k) Number: KOSO438 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K080438