Dental Unit

K142206 · Zhuhai Siger Medical Equipment Co., Ltd. · EIA · Mar 13, 2015 · Dental

Device Facts

• Record ID: K142206
• Device Name: Dental Unit
• Applicant: Zhuhai Siger Medical Equipment Co., Ltd.
• Product Code: EIA · Dental
• Decision Date: Mar 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 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.

Device Story

Dental unit (models U300, U500) serves as base/power supply for dental instruments; includes patient chair, instrument tray, operation light, assistant position, and pedal switch. Used in dental clinics by dentists/technicians. Operates via control panels or foot controller to manage chair positioning and instrument power. Provides stable platform and utility connections (water/air) for handpieces, scalers, curing lights, and syringes. Benefits patient by providing ergonomic, stable environment for dental procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance verified via testing to IEC 60601-1, IEC 60601-1-2, ISO 7494-1/2, ISO 6875, and ISO 10993-5/10.

Technological Characteristics

Dental unit with integrated chair. Materials: PU (armrest), PVC (upholstery), stainless steel (syringe), TPU (tubes). Power: 110V, 50/60Hz. Connectivity: ISO9168 compliant joints. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 7494-1/2 (dental units), ISO 6875 (chair), ISO 10993 (biocompatibility).

Indications for Use

Indicated for use in dental clinic/office environments by trained dentists, dental technicians, and assistants to provide power and a base for dental devices and accessories.

Regulatory Classification

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.

Predicate Devices

• Dental Unit with Chair S2310 (K130410)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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

- 1. 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: [phone] Fax: [phone] Email: [e-mail]

#### 3. Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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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:

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- 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<br>power to and serve as a base for dental<br>devices; and accessories. It is intended<br>for use in the dental clinic /office<br>environment and used by trained<br>dentists and/or dental technicians and<br>assistants. This product is attached with<br>a dental chair. | The Dental Unit with Chair is intended<br>to supply power to and serve as a base<br>for dental devices and accessories. It is<br>intended for use in the dental<br>clinic/office environment and used by<br>trained dentists and/or dental<br>technicians and assistants. This product<br>is attached with a dental chair. | |
| Features | Operating<br>Light | Halogen | LED |
| | Connection<br>Joint | Comply with ISO9168 | Comply with ISO9168 |
| | Water<br>Heating | Yes | No |
| Operation Method | Control Panel / Assistant Control Panel<br>/ Foot Controller | Control Panel / Assistant Control Panel<br>/ 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<br>Chair | Loading<br>Capacity | | 135Kg | 200kg |
| | Movement<br>Range<br>(Chair) | | 420-820 MM | 390mm-740mm |
| | Movement<br>Range<br>(Backrest) | | 0°~80° | 1°~70° |
| | | Movement<br>Range<br>(Headrest) | 200MM | 150mm |
| Accessories can be<br>attached to the device | | | Handpiece / Scaler / Curing Light /<br>Syringe | Handpiece / Scaler / Curing Light /<br>Three-way-Syringe |
| Performance Standards | | | Comply with ISO7494-1, ISO7494-2<br>and ISO6875 | Comply with ISO7494-1, ISO7494-2<br>and ISO6875 |
| Rate of Water<br>Suction | Suction | | ≥ 1L/min | 1 L/min |
| | Silva<br>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<br>Leather for patient chair: PVC<br>Syringe: Stainless steel Tubes:<br>TPU | PU, PVC, Polyamide, ABS, Stainless<br>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.