UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT

K040117 · Arrow Industries, LLC · EIA · Apr 21, 2004 · Dental

Device Facts

• Record ID: K040117
• Device Name: UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
• Applicant: Arrow Industries, LLC
• Product Code: EIA · Dental
• Decision Date: Apr 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

This device is intended to provide general restorative dental care to those who are unable to visit the dental office.

Device Story

UNIPORT is a self-contained, mobile dental operative unit designed for remote or off-site restorative dental care. The device integrates a 3/4 hp compressor, 9.8 L air storage, and operational components into a unitized, wheeled cabinet made of food-grade polyethylene. It provides manual control for two handpieces, an oil collection system, an autoclavable syringe, wet/dry foot control, and a self-contained water system. It also includes high-volume (HV) and saliva ejector vacuum systems. The device is operated by dental professionals to replicate standard clinic-based dental unit functions in non-clinical settings. The unit is designed for easy transport, set-up, and disinfection between operations.

Clinical Evidence

No clinical data. Substantial equivalence is based on descriptive comparisons of features and technical specifications to the predicate device.

Technological Characteristics

Unitized cabinet constructed of food-grade polyethylene; dimensions 36-3/4" x 19-7/8" x 20-3/4". Powered by 110 or 220 VAC. Features 3/4 hp compressor, 9.8 L air storage, air filter/dryer, and dual handpiece control. Includes HV and saliva ejector vacuum systems. Mechanical/pneumatic operation; no software or electronic algorithms.

Indications for Use

Indicated for patients unable to visit a dental office requiring general restorative dental care.

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 PAC I Portable Unit (K903451)

Submission Summary (Full Text)

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APR 2 1 2004

## Bob Symington

530 - STH STREET NECHE, ND 58265 PHONE [phone] FAX: [phone] TOLL FREE 1-866-865-7722

510(k) SUMMARY

Name of device: Common name: Classification name: Product code: Predicate device:

UNIPORT Mobile Dental Operative Unit Dental Operative Unit Class I EIA A-dec PAC I Portable Unit 510(k) number K903451 Dental Operative Unit Class I

This device is intended to provide general restorative dental care to those who are unable to visit the dental office.

The UNIPORT has been designed to provide ease in set-up and transportation as well as good dental care. Reliable air supply being an utmost necessity, it has 9.8 L of air storage supplied by a 3/4 hp compressor to maintain pressure during daily practice. For ease in set-up, take-down, and transport, the UNIPORT is truly self-contained - all components are mounted in a lightweight unitized cabinet with wheels. The cabinet, a shell containing the operational components, is made of food grade polyethylene for durability; its smooth exterior is easy to wipe down and disinfect between operations. While the outside of the UNIPORT appears different to others, the actual operating components are similiar to those used in dental clinics around the nation.

It has, of course been a constant imperative in the design of the UNIPORT device to replicate the functions of a standard dental operative unit such as the predicate device. A comparison of the relative features of the UNIPORT device to the features of the predicate device confirms that this has been achieved.

| UNIPORT Product Features: | PAC I Portable Unit Features: |
|-----------------------------------|-----------------------------------|
| Manual control for two handpieces | Manual control for two handpieces |
| Oil collection system | Oil collection system |
| Autoclavable syringe | Autoclavable syringe |
| Wet/dry foot control | Wet/dry foot control |
| Self-contained water bottle | Self-contained water system |
| 3/4 hp 110 or 220 VAC compressor | 1/2 hp 120 or 240 VAC compressor |

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| UNIPORT Product Features: | PAC I Portable Unit Features: |
|--------------------------------------------------------------|----------------------------------------------------|
| 9.8 liters of air storage | 4 liters of air storage |
| Air filter/dryer | Air filter regulator with moisture separator |
| HV and saliva ejector vacuum with<br>individual actuation | Air saliva ejector |
| One-piece molded plastic case<br>36-3/4" x 19-7/8" x 20-3/4" | Fixed-height mobile stand<br>33" x 21- $1$ " x 21" |
| Power bar for accessories | Duplex electrical outlet |

A comparison shows the UNIPORT to have the same features as the predicate device with a larger compressor and a greater air supply.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2004

Arrow Industries LLC Mr. Robert Symington 530 5" Street Neche, North Dakota 58265-4033

Re: K040117

Trade/Device Name: Uniport Self-Contained Portable Dental Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 6, 2004 Received: April 12, 2004

Dear Mr. Symington:

We have reviewed your Scction 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 Lederal Register.

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Page 2 - Mr. Symington

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); 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/dsma/dsmamain.html

Sincerely vours,

Ken Mulvey

Chiu Lin, Ph.D. 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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## Indications for Use

610(k) Number (ff known):____________________________________________________________________________________________________________________________________________________

Device Name: UNIPORT self-contained portable dental unit This device is intended for delivery of Indications for Use: general restorative dental care for those who cannot visit the dental office.

Prescription Use AND/OR (Part 21 CFR B01 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

'Robert Sher DDS for Dr. Susan Runner

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

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Koyoll 510(k) Number: J