(209 days)
Not Found
No
The description focuses on a mechanical system for cleaning water lines and does not mention any computational or learning capabilities.
No.
The device is intended to clean dental unit waterlines, not to treat a patient or a disease.
No
The device is described as a system for cleaning dental unit water lines using pressurized air and solutions, which is a maintenance function, not a diagnostic one.
No
The device description clearly states it is a "pressurized bottle system" and mentions injecting "pressurized air and than a solution," indicating it is a physical hardware device.
Based on the provided information, the C-1890 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean dental unit water lines. This is a maintenance and cleaning function for equipment, not a diagnostic test performed on biological samples (in vitro).
- Device Description: The device description confirms its function is to supply air and/or cleaning solution to water lines. This aligns with equipment maintenance, not diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological samples.
The predicate device listed (K962665 A-Dec Self-Contained Water System) also supports this conclusion, as it is a system for managing water in a dental unit, not an IVD.
N/A
Intended Use / Indications for Use
The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
Product codes
EIA
Device Description
The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.
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
JUN 1 9 2003
Dr. Thad Overmyer 514 South Third Street Danville, Ky 40422
Phone: 1-866-246-2548 Fax: 1-866-926-8246
"Premarket Notification 510{k} Summary"
-
- Submitter:
November 12, 2002 Dr. Thad Overmyer 514 South Third Street Danville, Kentucky 40422 Tel: 859-236-4778 Fax: 859-236-9136
- Submitter:
2. Name of Device
- A. Trade Name-C-1890
- B. Common name-Pressurized bottle system
- C. Classification Name: Unit, Operative Dental
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C-1890 is compared to the Class I device K962665 A-Dec Self-Contained Water System
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The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.
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Both systems are pressurized systems capable of supplying a solution from its reservoir. Both systems use similar fittings of similar materials. Both systems control the water with a switch. The C-1890 can inject pressurized air by a switch. The K962665 does not bave this switch for air purging. A shroud covers the tubing and valves of the C-1890 to prevent tampering. A heavy duty reservoir is included in both systems. The C-1890 has a preset air pressure regulator to assure the correct air pressure enters the system.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Dr. Thad Overmyer Anodia Systems 514 South Third Street Danville, Kentucky 40422
Re: K023896
Trade/Device Name: C-1890 Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: May 7, 2003 Received: May 9, 2003
Dear Dr. Thad Overmyer:
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.
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Page 2 - Dr. Thad Overmyer
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 (OS) 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Range
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): _K023896
Device Name: C-1890
Indications for Use:
The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution
(PLEASE DO NOT WIRTE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter Use
(Optional Format 1-2-9)
Saser Quares
(Division Sign Off
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K023896