(77 days)
Not Found
Not Found
No
The summary describes a physical filtration system for dental waterlines and makes no mention of AI or ML.
No.
The device is a filtration system for dental waterlines, designed to reduce contaminants in the water supply, not to treat a medical condition in a patient.
No
The device is a filtration system for dental unit waterlines, designed to reduce contaminants. It does not perform any diagnostic function such as identifying diseases or conditions.
No
The device description explicitly states it consists of "reusable filter housings and disposable filter elements," which are physical 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 filter water in dental unit waterlines to reduce contaminants. This is a water treatment system, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on filter housings and elements for water filtration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrolit existing dental waterlines.
Product codes
EIA
Device Description
The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrofit existing dental waterlines.
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)
Not Found
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/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 7 1999
Robert A. Dickstein, Ph.D. Senior Vice President Global Requlatory Affairs and Quality Assurance PALL Medical 2200 Northern Boulevard East Hills, New York 11548-1289
Re : K983735 Pall Dental Filtration System with Air Water Trade Name: Syringe Housing and Filter Membrane Regulatory Class: I Product Code: EIA 1998 Dated: October 21, October 22, 1998 Received:
Dear Dr. Dickstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Dickstein
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): 983735
Device Name: I'all Medical's Dental Unit Waterline Filtration System with
Air Water Syringe Housing and Filtration Membrane
Indications For Use:
Pall Medical's Dental Unit Waterline Filtration system safely and effectively reduces bacteriological contaminants and endotoxins, and waterborne particulate matter from dental waterlines. The system consists of reusable filter housings and disposable filter elements. This point-of-use system is designed to retrolit existing dental waterlines.
(Please do not write below this line-continue on another page if needed.)
Concurrence of CDRH, Office of Device Explayation (ODE)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number R98373
Prescription Use Or (Per 21 CFR 801.109)
Over-The Counter-Use (Optional Format 1-2-96)