(189 days)
Not Found
No
The summary describes a dental motor system for driving surgical tools, with no mention of AI or ML capabilities, image processing, or data-driven features.
No
The device is described as providing the driving force for instruments used to cut hard tissues in the mouth during dental oral surgery and dental implant procedures. It is a tool for performing a procedure, not a device that directly provides therapy or treatment.
No
This device is intended for driving dental handpieces and tools for cutting hard tissues in the mouth during dental oral surgery and dental implant procedures. It is an operative device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components such as Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), Stand, Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand, and Motor Shaft Plug. This indicates it is a hardware device with potential software control, not a software-only device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for use in dental oral surgery and dental implant procedures. They are designed to drive dental handpieces to cut hard tissues in the mouth. This is a direct surgical intervention on a living patient.
- Device Description: The description details how the device provides the driving force for dental instruments used in the mouth to perform operations.
- Anatomical Site: The specified anatomical site is the mouth, maxilla/mandible, which are parts of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. These devices do not perform such functions.
N/A
Intended Use / Indications for Use
C-Sailor Pro: This device is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER: The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth. This device is designed for use by a trained professional in the filed of general dentistry.
Product codes (comma separated list FDA assigned to the subject device)
EBW, KMW, EGS
Device Description
The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.
The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.
The two models of proposed device have the same operating principle shown as following:
The functions corresponding to the dental operation steps are preset by the mainframe or pedal switch, and the electric energy and signals are transmitted to the motor through the motor cable, the motor drives the motor handle, and the motor handle drives the dental surgical instruments to carry out the operation.
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
qualified dental personnel; trained professional in the filed of general dentistry.
hospital environments, clinics or dental offices
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:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests;
- IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
- ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
- ISO 10993-5 Biological evaluation of medical device -Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10 Biological evaluation of medical device - Part 10: Tests for irritation and skin sensitization.
- ISO 14971 Medical devices - Application of risk management to medical devices
- Bench Testing for the performance of Dimensions.
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
§ 872.4200 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 27, 2022
Foshan COXO Medical Instrument Co., Ltd. % Ray Wang Gerneral Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 CHINA
Re: K220831
Trade/Device Name: Dental Implantation Systems, Dental Electrical Motors Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EBW, KMW, EGS Dated: July 15, 2022 Received: July 18, 2022
Dear Ray Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220831
Device Name
Dental Implantation Systems/Dental Electrical Motors
Indications for Use (Describe)
C-Sailor Pro:
This device is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-PUMA MASTER:
The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth.
This device is designed for use by a trained professional in the filed of general dentistry.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
The assigned 510(k) Number: __K220831
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 Title 21, CFR Section 807.92.
-
- Date of Preparation: 07/15/2022
-
- Sponsor Identification
Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226, Guangdong, China
Contact Person: Zheng Yongjian Position: Legal Representative Tel: 13702544788 Fax: 0757-81800058 Email:13702544788@163.com
- Designated Submission Correspondent 3.
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401
Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Dental Implantation Systems, Dental Electrical Motors Common Name: Controller, Foot, Handpiece And Cord; Handpiece, Rotary Bone Cutting; Handpiece, Contra- And Right-Angle Attachment, Dental
Regulatory Information Classification Name: Dental Classification: 2 Product Code: EBW, KMW, EGS Regulation Number: 872.4120 Review Panel: Dental
Device Description:
The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.
The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.
The two models of proposed device have the same operating principle shown as following:
The functions corresponding to the dental operation steps are preset by the mainframe or pedal switch, and the electric energy and signals are transmitted to the motor through the motor cable, the motor drives the motor handle, and the motor handle drives the dental surgical instruments to carry out the operation.
Intended Use:
C-Sailor Pro:
This device is intended for use in dental oral surgery and dental implant.The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER:
The Dental Electrical Motor is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
This device is designed for use by a trained professional in the filed of general dentistry.
5
Predicate Device 510(k) Number: K173905 Product Name: Surgic Pro, Surgic Pro+ Manufacturer: NAKANISHI INC.
-
- 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:
- Non-Clinical Test Conclusion
-
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
-
EC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests;
-
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
-
ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
-
ISO 10993-5 Biological evaluation of medical device -Part 5: Tests for in vitro cytotoxicity. A
-
ISO 10993-10 Biological evaluation of medical device - Part 10: Tests for irritation and skin sensitization.
-
A ISO 14971 Medical devices - Application of risk management to medical devices
-
Bench Testing for the performance of Dimensions.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
| ITEM | Proposed Device | Predicate Device K173905 | Remark |
|---|---|---|---|
| Intended Use | C-Sailor Pro: | ||
| This device is intended for use in dental oral | |||
| surgery and dental implant. The main unit is | |||
| designed to be used with a specific dental | |||
| micromotor that drives dental handpieces fitted | |||
| with appropriate tools to cut hard tissues in the | |||
| mouth. | |||
| It must only be used in hospital environments, | |||
| clinics or dental offices by qualified dental | |||
| personnel. | |||
| C-PUMA MASTER: | Surgic Pro+ / Surgic Pro | ||
| The Surgic Pro+ / Surgic Pro is intended | |||
| for use in dental oral surgery and dental | |||
| implant. The main unit is designed to be | |||
| used with a specific dental micromotor | |||
| that drives dental handpieces fitted with | |||
| appropriate tools to cut hard tissues in | |||
| the mouth. | |||
| The SG20 and X-SG20L | |||
| This medical device is for oral surgery | |||
| and dental implant operation. This device | SAME | ||
| The Dental Electrical Motor is intended for use in | |||
| dental oral surgery and dental implant. The main | |||
| unit is designed to be used with a specific dental | |||
| micromotor that drives dental handpieces fitted | |||
| with appropriate tools to cut hard tissues in the | |||
| mouth. | |||
| This device is designed for use by a trained | |||
| professional in the filed of general dentistry. | is driven by an electronic micromotor for | ||
| oral surgery and dental implant. The | |||
| device is intended to transmit the | |||
| rotation of the power source at different | |||
| gear ratios, thereby moving instruments | |||
| such as surgical burs or surgical drills to | |||
| cut the maxilla / mandible during oral | |||
| surgery and dental implant. | |||
| Indications for Use | Prescription Use, dental oral surgery, dental | ||
| implant | Prescription Use, dental oral surgery, | ||
| dental implant | SAME | ||
| Package Contents | Host | ||
| Foot Control (With Cable) | |||
| AC Electrical Cord | |||
| Motor (With Cable) | |||
| Stand | |||
| Handpiece Stand | |||
| Tube Holder | |||
| Spare Fuse | |||
| Handle(Foot control) | |||
| Irrigation tubing set | Control Unit | ||
| Micromotor (Optic or Non-Optic) | |||
| Foot Controller | |||
| Handpiece (Optic or Non-Optic) | |||
| Irrigation tube (5 pcs) | |||
| Operation Manua | Analysis 1 | ||
| Memory | 8 Pre-set implant systems | 8 Pre-set implant systems | |
| 8 user defined | |||
| of 8 steps each | SAME | ||
| Micromotor Torque | C-Sailor Pro: 5 - 80Ncm | ||
| C-PUMA MASTER: 0.6-5.1Ncm | 5 - 80Ncm | SAME | |
| Maxima speed | C-Sailor Pro: 300r/min~40000r/min | ||
| C-PUMA MASTER: 2000~40000rpm | 200-40,000 min-1 | Analysis 2 | |
| Speed ratio option | C-Sailor Pro: 64:1, 20:1, 16:1, 10:1, 4:1, 1:1, 1:5 | ||
| C-PUMA MASTER: 16:1, 1:1, 1:5 | Not available | Analysis 3 | |
| Discharge | C-Sailor Pro: ≥50ml/min | ||
| C-PUMA MASTER: ≥50ml/min(200kPa) | Not available | ||
| Spray gas flow rate | C-Sailor Pro: / | ||
| C-PUMA MASTER: ≥1.5L/min(200kPa) | Not available | ||
| Cooling gas flow | C-Sailor Pro: / | ||
| C-PUMA MASTER: |