(74 days)
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Not Found
No
The summary describes a dental relining material and does not mention any AI or ML components or functionalities.
Yes
The device is intended to relieve pressure, cushion alveolar processes, and support healing, which are therapeutic actions.
No
The intended uses listed describe a material for relining dentures and for therapeutic/supportive purposes (e.g., relieving pressure, cushioning, supporting healing), rather than for identifying or diagnosing a disease or condition.
No
The intended use describes a physical material (soft relining) for dentures, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for relining dentures and addressing issues within the mouth (relieving pressure, damming the palatal vibrating line, cushioning alveolar processes, supporting healing). This is a direct interaction with the patient's anatomy and a physical application within the body.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The description of SECURE SOFT does not involve any such testing or analysis of specimens.
Therefore, SECURE SOFT falls under the category of a medical device used for direct patient care and treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
SECURE SOFT is intended for use as permanently soft relining for total and partial dentures.
- To relieve pressure from pressure spots .
- To dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
- To cushion sharp-edged alveolar processes .
- To support the healing process in implantology
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 (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)
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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.
0
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, one behind the other.
JUL 1 9 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brad Vance Director of Regulatory Affairs & New Projects Coordinator IMTEC Corporation 2401 North Commerce Ardmore. Oklahoma 73401
Re: K021437
Trade/Device Name: Secure Soft Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 3, 2002 Received: May 6, 2002
Dear Mr. Vance:
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 mav, 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.
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.
1
Page 2 - Mr. Vance
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Internetaddress http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucurullofa
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510 (K) Number (if known): _
SECURE SOFT Device Name:
Indications For Use:
SECURE SOFT is intended for use as permanently soft relining for total and partial dentures.
- To relieve pressure from pressure spots .
- · To dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
- To cushion sharp-edged alveolar processes .
- . To support the healing process in implantology
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Or
Over - The - Counter Use
(Per 21 CFR 801.109)
Susan Puma
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number_il 00