(141 days)
Not Found
Not Found
No
The 510(k) summary describes a dental reline material and does not mention any AI or ML components.
No
The device is described as a hard liner and repair material for removable dentures, which is a restorative or prosthetic material, not a device used to treat a disease or condition.
No
The device description states it is a "hard liner and repair material for removable dentures", which indicates it is a therapeutic or restorative device, not a diagnostic one.
No
The device description clearly states "Hard Reline Liquid" and "LINER I: HARD RELINE LIQUID," indicating a physical material used for dentures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used as a hard liner and repair material for removable dentures." This describes a material used on a medical device (dentures) for repair and lining, not a test performed on a biological sample to diagnose or monitor a medical condition.
- Device Description: The description "LINER I: HARD RELINE LIQUID" further supports its use as a material for dentures.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Diagnosing or monitoring a disease or condition
- Analyzing biomarkers or other biological indicators
Therefore, based on the provided text, this device falls under the category of a dental material used for the repair and modification of dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hard Reline Liquid is used as a hard liner and repair material for removable dentures.
Product codes
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its head and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 OCT
Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
K981861 Re: Trade Name: Liner 1: Hard Reline Liquid Requlatory Class: II Product Code: EBI September 15, 1998 Dated: Received: September 23, 1998
Dear Ms. Goldstein:
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 leqally 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 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 (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. A 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 regulation (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 - Ms. Goldstein
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 findinq of substantial equivalence of your device to a leqally 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 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" (CFR 807.97). Other qeneral 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,
Patricia Cucurita/for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image shows a sequence of numbers and a letter. The letter K is on the left side of the image. To the right of the letter K is the number 981861. The numbers and letters are in bold font.
Page ____ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Number: K981861
Device Name: LINER I: HARD RELINE LIQUID
INDICATIONS FOR USE:
Hard Reline Liquid is used as a hard liner and repair material for removable dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) . . . . . . . . . . . :
Concurrence of CDRH, Office of Device Evaluation (ODF)
Prescription Use (Pcr 21 CFR 801.109)
: 上
OR
Over-the-Counter Use
(Optional Formal 1-2-96)
Susan Russo
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K981861