(178 days)
Not Found
No
The 510(k) summary describes a standard dental unit with mechanical and electrical components, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a dental unit that supplies power and serves as a base for dental devices. It is not directly therapeutic but rather supports therapeutic procedures performed by dental professionals.
No
The device is a dental unit that supplies power and serves as a base for other dental devices and accessories, including a dental chair. It is used for patient treatment procedures and operations, not primarily for diagnosis.
No
The device description clearly outlines multiple hardware components including a patient chair, dentist element, assistant element, side cabinet support center, foot control, cuspidor, and dental operating light. The performance studies also include testing related to hardware components like biocompatibility, reprocessing validation, electrical safety, and performance testing according to hardware standards (ISO 7494-1, ISO 7494-2, and ISO 9168). While software verification and validation are mentioned, it is in the context of controlling these hardware components.
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 and serve as a base for dental devices and accessories, including a dental chair, for use in patient treatment procedures. This is a functional device for supporting dental procedures, not for performing tests on samples taken from the human body.
- Device Description: The description details the components of a dental unit (chair, elements, controls, etc.) which are used to facilitate dental procedures on a patient. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on biocompatibility, reprocessing, electrical safety, EMC, and performance according to dental unit standards (ISO 7494-1, ISO 7494-2, ISO 9168). These are relevant to a dental unit, not an IVD.
In vitro diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This dental unit does not perform such functions.
N/A
Intended Use / Indications for Use
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Product codes
EIA, KLC
Device Description
The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
Components: The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation, these components are devices such as dental handpieces can be connected to the dental unit. Dental handpieces are not included in the BDC Dental Unit. The components of the BDC Dental unit are intended to be covered with an FDA cleared disposable barrier and reprocessed (e.g., cleaning, disinfection, and/or sterilization) per the instructions for use.
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 dental professionals, dentists and/or dental assistants.
dental clinic 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 Test Data:
- Biocompatibility testing: ISO 10993-5: 2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cvtotoxicity; ISO 10993- 10: 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization. Tests included Cytotoxicity, Sensitization, and Irritation. The tubing and syringes body are considered as indirect tissue contacting.
- Reprocessing Validation: Conducted per FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (fda.gov)" including cleaning, disinfection, and sterilization validation for the components. Cleaning and Sterilization validation was conducted for the 3-way syringe tip. Cleaning and disinfection validation was provided for the surfaces and for the waterlines and water bottles of the subject device using standard 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment.
- Electrical safety and electromagnetic compatibility (EMC): Tests performed in accordance with IEC 60601-1-2 and IEC 60601-1. Also IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment.
- Software Verification and Validation Testing: Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." Software considered "BASIC" level of concern.
- Performance Test: Conducted as bench test, results met pre-set criteria. Standards used: ISO 7494-1 Third edition 2018-06 - Dentistry - Dental units - Part 1: General requirements and test methods; ISO 7494-2 Second edition 2015-01 - Dental units - Part 2: Water and air supply; ISO 9168 - 2009-07- 15 - Dentistry - Hose connectors for air driven dental handpieces devices.
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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February 7, 2025
BDC Dental Corporation Ltd. % Dave Kim FDA Regulatory Consultant Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K242404
Trade/Device Name: BDC Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I, reserved Product Code: EIA, KLC Dated: January 10, 2025 Received: January 10, 2025
Dear Dave Kim:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
2
assistance/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 -S
Michael Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
K242404
Device Name
BDC Dental Unit
Indications for Use (Describe)
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY K242404
I. SUBMITTER
| Date: | February 4, 2025 |
|---|---|
| Submitter's Name: | BDC Dental Corporation Ltd. |
| Submitter's HQ Address: | Part 3, No. 1 Guanchong Section, Shilian Rd., Shiqi Town, Panyu District, Guangzhou, 511450 Guangdong, P.R.China |
| Submitter's Telephone: | 020-32052929 |
| Contact Person: | Yanfei Liu, mr@o-bdc.com, RA Manager |
II. PROPOSED DEVICE
| Trade/proprietary Name: | BDC Dental Unit |
|---|---|
| Model Name: : | N1, N2, N3, N1 Plus, N2 Plus, N3 Plus, S1, S2, S3, S1 Plus, S2 Plus, S3 Plus |
| Regulation Name: | Dental Operative Unit and Accessories |
| Regulation Number: | 21 CFR 872.6640 |
| Product Code: | EIA, KLC |
| Regulatory Class: | Class I, reserved |
III. PREDICATE DEVICE
| 510(k) Number: | K213932 |
|---|---|
| Primary Manufacturer: | A-dec Inc. |
| Device Name: | A-dec 500 |
| Regulation Name: | Dental Operative Unit and Accessories |
| Regulation Number: | 21 CFR 872.6640 |
| Product Code: | EIA |
| Regulatory Class: | Class I, reserved |
IV. DEVICE DESCRIPTION
The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
Components: The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation, these components are devices such as dental handpieces can be connected to the dental unit. Dental handpieces are not included in the BDC Dental Unit. The components of the BDC Dental unit are intended to be covered with an FDA cleared disposable barrier and reprocessed (e.g., cleaning, disinfection, and/or sterilization) per the instructions for use.
5
Brief of differences between all models
| Model | Dentist
Element
(Traditional) | Dentist
Element
(Traditional
Cart Type) | Dentist
Element
(Continental) | Dentist
Element
(Continental
Cart Type) | Left/right
Arm
Swivel | Disc
foot
control | Lever
foot
control |
|---------|-------------------------------------|--------------------------------------------------|-------------------------------------|--------------------------------------------------|-----------------------------|-------------------------|--------------------------|
| N1 | √ | | | | | √ | |
| N2 | | √ | | | | √ | |
| N3 | √ | | | | | | √ |
| N1 Plus | | | √ | | | √ | |
| N2 Plus | | | | √ | | √ | |
| N3 Plus | | | √ | | | | √ |
| S1 | √ | | | | | √ | |
| S2 | | √ | | | √ | √ | |
| S3 | √ | | | | √ | | √ |
| S1 Plus | | | √ | | √ | √ | |
| S2 Plus | | | | √ | √ | √ | |
| S3 Plus | | | √ | | √ | | √ |
V. INDICATIONS FOR USE
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 2
| Items | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Manufacturer | BDC Dental Corporation Ltd. | A-dec Inc. | |
| 510(k) Number | K242404 | K213932 | |
| Product name | Dental Unit | A-dec 500 Delivery System | |
| Model | N1, N2, N3, N1 Plus, N2 Plus, N3 | ||
| Plus, S1, S2, S3, S1 Plus, S2 Plus, S3 | |||
| Plus | A-dec 500 | ||
| Design | The BDC dental unit is mainly | ||
| composed of a patient chair, dentist | |||
| element(tray table, 3-way syringe), | |||
| assistant element (3-way syringe, | |||
| high volume evacuator and saliva | |||
| ejector), side cabinet support center, | |||
| foot control, cuspidor and a dental | |||
| operating light. | A-dec 500 dental system is | ||
| composed of dental chair, delivery | |||
| system, assistant arm, dental light, | |||
| cuspidor. | Similar | ||
| Indications for Use | The BDC Dental Unit is intended to | ||
| supply power to and serve as a base | |||
| for dental devices and accessories. | |||
| This device includes a dental chair | |||
| and is intended for use in the dental | |||
| clinic environment and is designed | |||
| for use by trained dental | |||
| professionals, dentists and/or dental | |||
| assistants. | The A-dec Delivery System is | ||
| intended to provide a mounting | |||
| location in addition to providing | |||
| air, water, vacuum, and electrical | |||
| power to dental devices for use | |||
| during diagnostic and therapeutic | |||
| treatment by licensed health care | |||
| professionals. Delivery systems | |||
| may be mounted to dental chairs, | |||
| dental carts, | |||
| dental cabinets, and walls. | Similar | ||
| Dentist Element | - Control of water and air supply, | ||
| Table Height, Patient Chair | |||
| Positioning, Light On/Off, Handpiece | |||
| Function, Timer, Mode Selection | -Turn on/Turn off the air, water, | ||
| and power, Position the Delivery | |||
| System, Position the Handpiece | |||
| Holders, Operate Touchpad | |||
| Lockout, User Setting and | |||
| Auxiliary Device Control, | |||
| Position the Chair, Operate the | |||
| Dental Light, Operate the | |||
| Cuspidor, Operate Handpiece | Same | ||
| Assist Table | |||
| (Assistant | |||
| Element) | - Components: 3-way Syringe, Saliva | ||
| Ejector, High Volume Evacuator | |||
| (Large Saliva Ejector) |
- Control of Light On/Off, Cup/
Spittoon (Cuspidor) Water Dispenser,
Changing the Settings, Position
memories | -Components: Syringe, Saliva
Ejector, High Volume Evacuator
-Position the Handpiece
Holders, Adjust the
Worksurface and
Instrumentation Height, Operate
the Dental Light,
Operate the Cuspidor | Same |
| Main Components | The BDC dental unit is mainly
composed of a patient chair, dentist
element(tray table, 3-way syringe),
assistant element (3-way syringe,
high volume evacuator and saliva
ejector), side cabinet support center,
foot control, cuspidor and a dental
operating light. | Dental system is composed of
dental Chair , delivery system,
assistant arm, dental light ,
cuspidor. | Same |
| Control of water
and air | Uses pneumatically controlled vales
to water control the flow of air and
water on /off and intensity controlled
by foot control. | Use air coolant and water
coolant to adjust Air and water,
speed controlled by foot control. | Same |
| Software-
controlled
components | Software functions are reflected in
the dentist element and assistant
element panel .Software can control
dental patient chair up, down, tilt
forward, tilt backward and set
treatment position, dental operating
light on/off, cuspidor flush and cup-
filler. | Software functions are reflected
in the delivery system and
assistant arm panel .
Software can control dental chair
base up, down, and set treatment
position, dental light on/off/
intensity, bowl flush and
cupfill, handpieces, electric
handpiece. | Similar |
| Table
(Dentist Element) | - Control of water supply, scaler
vibration power, table height,
patient
position, System Power, Film viewer,
Patient Chair Positioning, Light
On/Off, Handpiece function, Timer,
Mode Selection, LED Display | - Control of water and air supply,
Table Height, Patient Chair
Positioning, Light On/Off,
Handpiece Function, Timer,
Mode Selection | Similar |
| Assist Table
(Assistant
Element) | - Accessories: Saliva Ejector
(Small,
Large), 3-way Syringe - Control of
Light On/Off, Cup/Spittoon Water
Dispenser, Changing the Settings,
Position memories | - Components: 3-way Syringe,
Saliva Ejector, High Volume
Evacuator (Large Saliva
Ejector) - Control of Light On/Off, Cup/
Spittoon (Cuspidor) Water
Dispenser, Changing the
Settings, Position memories | Same |
| Main Components | Chair, Unit, Table, Seat, Stool, Monitor
Arm, Operation table | Chair, Unit (side cabinet support
center), Table (Assistant Element),
Seat (Upholstery Seat), Stool,
Operation table (Dentist Element) | Same |
| Power& Utility
Supply | AC110- 120 / 220-240V,
50/60Hz, compressed air and water | AC100- 120/220-240V, 50/60Hz,
compressed air and water | Same |
| Syringe | 3-way syringe | 3- way syringe | Same |
| Control of water
and air | Uses pneumatically controlled vales to
water control the flow of air and water
on/off and intensity controlled by foot
pedal | Uses pneumatically controlled vales
to water control the flow of air and
water on /off and intensity
controlled by foot pedal. | Same |
| Air Pressure | 0.55-0.8MPa / 5.5-8.0bar | 550kPa(min)/800kPa(max) | Similar |
| Water Pressure | 0.20-0.40MPa / 2.0-4.0bar | 410±140 kPa | Similar |
| Dental unit
handpiece hose | Air flow rate:300Kpa,max.68NL/min
Spray air
flowrate:250Kpa,max.18NL/min
Water flow rate:250Kpa,max.75mL/min | N/A | |
| Water System | City water supply | City water supply | Same |
| Water Heater | Max. (