(47 days)
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No
The summary describes a silicone reliner for dentures, a purely physical material, and contains no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as providing a "soft tissue-bearing surface to the denture for patient comfort," which implies it is used to alleviate pain or improve quality of life, aligning with the definition of a therapeutic device.
No
The device, "TUF LiNK Silicone Reliner," is described as being applied to dentures to provide a soft tissue-bearing surface for patient comfort. Its intended use is therapeutic (comfort), not for diagnosing any medical condition or disease.
No
The intended use describes a physical material (silicone reliner) applied to dentures, indicating a hardware component.
Based on the provided information, the TUF LiNK Silicone Reliner is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a soft tissue-bearing surface for dentures for patient comfort. This is a direct application to a medical device (denture) for a therapeutic/comfort purpose, not for testing a sample from the human body to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the TUF LiNK Silicone Reliner falls under the category of a dental material or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TUF LiNK Silicone Reliner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2004
Mr. Thomas Murphy Chief Executive Officer Dentatus USA, Limited 192 Lexington Avenue New York, New York 10016
Re: K042931
Trade/Device Names: Tuf Link™ Resilient Silicone Reliner Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: October 19, 2004 Received: November 03, 2004
Dear Mr. Murphy:
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 - Mr. Thomas Murphy
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 (240) 276-0115. 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 Chang
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K 042931
510(k) Number (if known):
Device Name:
Indications for Use:
TUF LiNK Resilient Material Silicone Reliner
TUF LiNK Silicone Reliner is applied to acrylic dentures for the TOF ENRS Officency to epport.
purpose of providing a soft tissue-bearing surface to the denture for patient comfort.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
Suren Runoeg
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: K040631
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