(55 days)
Kooliner
Not Found
No
The summary describes a material for relining dentures and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device restores function and comfort to ill-fitting dentures, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a denture reline material intended for restoring function and form in ill-fitting dentures, not for diagnosing a condition.
No
The device is a paste/paste methacrylate based system, which is a physical material, 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 for restoring the function and form of dentures due to alveolar bone loss. This is a direct treatment/restoration applied to a medical device (denture) that is used externally by the patient.
- Device Description: The device is a paste/paste system for relining dentures. This is a material used to modify a medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the patient's denture, which is then placed in the mouth) or ex vivo (in a dental lab to modify the denture).
N/A
Intended Use / Indications for Use
The intended use of Kerr Hard Denture Reline Material is for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.
Product codes
EBI
Device Description
The device is a paste/paste methacrylate based system for restoring function, comfort and esthetics to ill-fitting dentures. The system can be used either in the dental office or in the dental laboratory for relining of dentures.
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
dental office or in the dental laboratory
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Kooliner, GC America
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the date JUN 16 1998 at the top. Below the date is the name SYBRON in large, bold letters. Underneath the name is the text DENTAL SPECIALTIES, INC.
Ka8 1448
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7425 - Phone (714) 516-7488 - Facsimile Wendy A. Urtel - Contact Person
Date Summary Prepared: April 1998
Device Name:
- Trade Name Kerr Hard Denture Reline Material ●
- Common Name Hard Denture Reline Material ●
- Classification Name Denture Relining, Repairing or Rebasing Resin . 21 CFR § 872.3760
Device for Which Substantial Equivalence is Claimed:
- Kooliner, GC America ●
Device Description:
The device is a paste/paste methacrylate based system for restoring function, comfort and esthetics to ill-fitting dentures. The system can be used either in the dental office or in the dental laboratory for relining of dentures.
Intended Use of the Device:
The intended use of Kerr Hard Denture Reline Material is for the restoration of function and form in dentures which have become ill-fitting due to alveolar bone loss over a period of time.
Substantial Equivalence:
The hard denture reline material is substantially equivalent to other legally marketed devices in the United States. The hard denture reline material marketed by GC America functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Corporation.
Image /page/0/Picture/19 description: The image shows a recycling symbol next to the text "Printed on Recycled Paper". The recycling symbol is a circular arrow made up of three arrows chasing each other. The text is in a simple, sans-serif font and is right-aligned to the recycling symbol. The image is likely used to indicate that the paper used for printing is made from recycled materials.
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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 stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 1998
Ms. Wendy A. Urtel Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92667
K981448 Re : Kerr Hard Denture Reline Material Trade Name: Requlatory Class: II Product Code: EBI Dated: April 17, 1997 Received: April 22, 1998
Dear Ms. Urtel:
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 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, Druq, 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. বৈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Urtel
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 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" (21 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr
Division of Dental, Infection Control. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section I - Indications for Use
510(k) Number: K981442
Device Name: Kerr Hard Denture Reline Material
Indications for Use:
لقابل المنتخب
Kerr Hard Denture Reline Material is intended for the restoration of function and form in Rell Hard Denture Remis Material in the new lass over a period of time.
Susan Rumm
l
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ( ILILIX