(214 days)
No
The 510(k) summary describes a standard dental unit that provides power and serves as a base for other dental devices. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on electrical safety, electromagnetic compatibility, and general dental unit standards, not AI/ML performance metrics.
No.
The device description states its purpose is to supply power to and serve as a base for dental devices and accessories, rather than directly treating a condition or disease.
No
The device description states its purpose is to "supply power to and serve as a base for dental devices and accessories," which indicates it is a support system rather than a device intended for diagnosis. There is no mention of diagnostic functions, readings, or interpretations.
No
The device description explicitly lists physical components like instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "supply power to and serve as a base for dental devices; and accessories." This describes a piece of equipment used in a clinical setting to support other dental tools. It does not mention analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Device Description: The description details the physical components of the dental unit (instruments, arm tray, cabinet, light, etc.). It does not describe any components or functions related to performing tests on biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, test results, or any other typical characteristics of an IVD device.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, and compliance with standards related to dental units and patient chairs. They do not involve studies related to diagnostic accuracy or performance on biological samples.
In summary, the device is a piece of dental equipment used to facilitate dental procedures, not a device used to perform diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Dental Unit 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
EIA
Device Description
The proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair.
The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.
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
trained dentists and/or dental technicians and assistants. It is intended for use in the dental clinic /office environment
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)
Non clinical 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: 2005 +COOR.1 (2006) + CORR.2 (2007), Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - 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: 2011, Dentistry -- Patient chair
- ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2015
Zhuhai Siger Medical Equipment Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K142206
Trade/Device Name: Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: January 21, 2015 Received: February 12, 2015
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.
1
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/Resourcesfor You/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.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142206
Device Name Dental Unit
Indications for Use (Describe)
The Dental Unit 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K142206
510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K142206
-
- Date of Submission: 01/20/2015
2. Sponsor Identification
Zhuhai Siger Medical Equipment Co., Ltd Building 2, No. 1 Chuangxin Yi Road, Tangjiawan Town, Zhuhai City, Guangdong, China
Establishment Registration Number: Not yet registered
Contact Person: Huisheng Wang Position: General Manager Tel: 86 13802677946 Fax: 86 756 3881011 Email: wanghs@siger.cn
3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
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4. Proposed Device Identification
Proposed Device Name: Dental Unit Proposed Device Model: U300, U500 Proposed Device Common Name: operative dental unit
Regulatory Information: Classification Name: Unit, Operative Dental Classification: I Product Code: EIA Regulation Number: 21 CFR 872.6640 Review Panel: Dental
Intended Use Statement:
to The Dental Unit 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."
5. Predicate Device Identification
510(k) Number: K130410 Product Name: Dental Unit with Chair S2310 Manufacturer: Xianyang North West Medical Instrument (Group) Co., Ltd
6. Device Description
The proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair.
The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.
7. Non-Clinical Test Conclusion
Non clinical 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:
5
- IEC 60601-1: 2005 +COOR.1 (2006) + CORR.2 (2007), Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - 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: 2011, Dentistry -- Patient chair
- ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Devices | Predicate Device | |
|---|---|---|---|
| Product Code | EIA | EIA | |
| Regulation No. | 21 CFR 872.6640 | 21 CFR 872.6640 | |
| Class | 1 | 1 | |
| Intended Use | The Dental Unit 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. | |||
| Features | Operating | ||
| Light | Halogen | LED | |
| Connection | |||
| Joint | Comply with ISO9168 | Comply with ISO9168 | |
| Water | |||
| Heating | Yes | No | |
| Operation Method | Control Panel / Assistant Control Panel | ||
| / Foot Controller | Control Panel / Assistant Control Panel | ||
| / Foot Controller | |||
| Power Supply | 110V | 110V | |
| Frequency | 50/60Hz | 50/60Hz |
Table 3-1 Comparison of Technology Characteristics
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| Power (with dental chair) | 900VA | 400VA | ||
|---|---|---|---|---|
| Pressure of Water Supply | 200 kPa ~ 400 kPa | 0.2MPa-0.4MPa | ||
| Pressure of Air Supply | ≥550 kPa | 0.55MPa | ||
| Dental | ||||
| Chair | Loading | |||
| Capacity | 135Kg | 200kg | ||
| Movement | ||||
| Range | ||||
| (Chair) | 420-820 MM | 390mm-740mm | ||
| Movement | ||||
| Range | ||||
| (Backrest) | 0°~80° | 1°~70° | ||
| Movement | ||||
| Range | ||||
| (Headrest) | 200MM | 150mm | ||
| Accessories can be | ||||
| attached to the device | Handpiece / Scaler / Curing Light / | |||
| Syringe | Handpiece / Scaler / Curing Light / | |||
| Three-way-Syringe | ||||
| Performance Standards | Comply with ISO7494-1, ISO7494-2 | |||
| and ISO6875 | Comply with ISO7494-1, ISO7494-2 | |||
| and ISO6875 | ||||
| Rate of Water | ||||
| Suction | Suction | ≥ 1L/min | 1 L/min | |
| Silva | ||||
| Ejector | > 750mL/min | 750ml/min | ||
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | ||
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | ||
| Patient Contact Material | Armrest: PU | |||
| Leather for patient chair: PVC | ||||
| Syringe: Stainless steel Tubes: | ||||
| TPU | PU, PVC, Polyamide, ABS, Stainless | |||
| steel |
The proposed devices, Dental Unit U300 and U500, are determined to be Substantially Equivalent (SE) to the predicate device, Dental Unit with Chair S2310 (K130410), with respect to intended use, technological characteristics and principles of operation.