(92 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a portable dental unit, with no mention of AI or ML capabilities.
No
The device is a portable dental unit that delivers general restorative dental care. While it facilitates therapeutic procedures, it is itself an instrument that provides power and air to dental tools, rather than directly applying a therapeutic effect.
No
The device description and intended use indicate that this device is for performing general restorative dental care, which is a treatment, not a diagnostic, function.
No
The device description clearly outlines physical components like an air compressor, air storage, a cabinet with wheels, and operational components similar to those in dental clinics, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivery of general restorative dental care." This involves direct treatment of a patient's teeth and mouth.
- Device Description: The description details a portable dental unit with components like an air compressor and cabinet, designed for performing dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples from the human body to provide diagnostic information. This device is a tool for performing dental procedures directly on a patient.
N/A
Intended Use / Indications for Use
This device is intended to provide general restorative dental care to those who are unable to visit the dental office.
Product codes
EIA
Device Description
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.
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
Not Found
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)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Arrow Industries. The word "ARROW" is in large, bold, black letters. Underneath the word "ARROW" is a thick black line that extends to the right and forms an arrow. Below the line, the word "INDUSTRIES" is written in smaller, bold, black letters.
APR 2 1 2004
Bob Symington
530 - STH STREET NECHE, ND 58265 PHONE 1-701-886-7722 FAX: (701) 886-7622 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 |
1
| 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 | |
| individual actuation | Air saliva ejector |
| One-piece molded plastic case | |
| 36-3/4" x 19-7/8" x 20-3/4" | Fixed-height mobile stand |
| 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.
2
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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
4
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Koyoll 510(k) Number: J