BOYD DELIVERY UNIT

K020833 · Boyd Industries, Inc. · EIA · Aug 8, 2002 · Dental

Device Facts

• Record ID: K020833
• Device Name: BOYD DELIVERY UNIT
• Applicant: Boyd Industries, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Indications for Use

The Boyd Delivery Unit is intended to supply utilities to and serve as a base for dental tools and accessories. The use of this device does not differ significantly from the predicate dental operative units.

Device Story

Boyd Delivery Unit serves as a dental operatory interface device; connects hand instruments to supply utilities including air, water, suction, drain, and electricity. Functions as a system management device; allows operator to control air pressure and water flow to handpieces and syringes via a single control input. Features include stackable design, assistant's instrumentation delivery system, water heater, and cuspidor. Used in dental clinics by dentists or operators to manage hand instruments. Output consists of regulated utility supply to dental tools; enables clinical procedures by providing necessary power and fluid management for dental instrumentation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental operative unit; cabinet-mounted. Provides high-speed/low-speed handpiece hookups, 3-way syringe, saliva ejector, and high-volume evacuation. Features master on/off valve, handpiece toggle switches, foot control, and air flush system. Water system is self-contained. Mechanical/pneumatic/hydraulic operation.

Indications for Use

Indicated for use by dental professionals for the effective treatment of patients.

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

• a-dec (K000966)
• DentalEZ (K931204)

Reference Devices

• Marus Dental

Submission Summary (Full Text)

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## 510(k) SUMMARY

- 1) Boyd Industries, Inc. 12900 44th Street North Clearwater, FL 33762 US Phone: [phone] Fax: [phone] Contact: Bruce Livingston Establishment Registration Number: 1062917 (reference next page) Date of Submission: March 8, 2002
- 2) Trade Name: Boyd Delivery Units Common Name: Delivery System Classification Name: Dental Operative Unit and Accessories
- 3) Equivalent Device:

The Boyd Delivery Unit is substantial to similar Dental Operative Unit and Accessories previously cleared with the FDA for marketing in the United States, using the same basic technology, design process and attention to safety. Copies of product literature are included in Section 1 and Comparison Data is included in section 2 of this submittal.

- 4) Technical Description:
The Boyd Delivery Unit is a Dental Operative Unit that provides the dentist with primary requirements for a dental operatory. The delivery system is designed to be used as an interface device to connect the dental operatory hand instruments to the appropriate supply utility such as air, water suction, drain and electricity. It functions as a system management device that provides a method of operating various hand instruments from a single control input device. The unit is furnished with controls that allow the dentist or operator to set the air pressure and water flow to the hand pieces and the syringe in the delivery head. The unit is of a stackable design providing a base for dental tools and accessories. Assistant's instrumentation delivery system, water heater, and the cuspidor are all features that this unit can offer.

- 5) Intended use. The Boyd Delivery Unit is intended to supply utilities to and serve as a base for dental tools and accessories. The use of this device does not differ significantly from the predicate dental operative units.
## 6) Comparison of device to marketed devices

Reference chart "Comparison of device to marketed devices" on the following page.

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isting from FDA Websit Ticial Correspondent Name: MR. BRUCE LIVING:
Toial Correspondent Phone: Number: 727-561-929
Torial Correspondent Phone: Number: 727-561-9299
000-44TH STREET, INC.
EARWATER, F Setablishment Names
2900 44TA STREET NYON
2017 ATTA STREET NYON
CLEAR ANTAL STREET NYONE Nomber: 10629 17
Stablishment Operationa: Commont Manufactu
Sate of Rugustionar: Cont Owner/Operator:
BOYD INDUSTRUES, INC.
I2900 44TH STRIEST NORTH
CLEARWATERS FLE 33722
CLEARWATERS, FL 33722
Owner/Operator Number: 90303

# omparison of device to marketed device

| Feature | Boyd Industries, Inc. | a-dec (K000966) | DentalEZ (K931204) | Marus Dental |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Mounting unit | Cabinet | Cabinet | Cabinet | Cabinet |
| Instruments<br>Available | High-speed handpiece hookup, low<br>speed handpiece hookup, 3-way<br>syringe, saliva ejector, high volume<br>evacuation with solids collector | High-speed handpiece hookup, low<br>speed handpiece hookup, 3-way<br>syringe, saliva ejector, high volume<br>evacuation with solids collector | High-speed handpiece hookup, low<br>speed handpiece hookup, 3-way<br>syringe, saliva ejector, high volume<br>evacuation with solids collector | High-speed handpiece hookup, low<br>speed handpiece hookup, 3-way<br>syringe, saliva ejector, high volume. |
| Activation | Master off/on valve, handpiece<br>toggle switch and foot control | handpiece toggle switch and foot<br>control | Master off/on valve, handpiece<br>toggle switch and foot control | Automatic activation for each<br>handpiece |
| Cleaning | Air flush system | Water flush | Water flush | Water flush |
| Water System | Self contained | Self contained | City hook up or self contained | City hook up |

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 0 8 2002

Mr. Bruce Livingston Boyd Industries, Incorporated 12900 44th Street North Clearwater, Florida 33762

Re: K020833

Trade/Device Name: Boyd Delivery Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 14, 2002 Received: June 27, 2002

Dear Mr. Livingston:

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.

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.

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Page 2 - Livingston

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulatsowski

A. Ulatowski Timot 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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# 33

Pege. ........................................................................................................................................................................

510(k) Number (if known)

Device Name:

Indications For Use:

.

Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurence of CDRH, Office of Device Evaluation (ODF)

Prescription Usey (Per 21 CFR 801,109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Swar Rumpie

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Oractrol Devices Division of Anesthesionsy, Dental Devices

510(k) Number. k020833