(31 days)
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No
The summary describes a dental resin material and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a "hard relining / pickup material" for dentures, which is a restorative or prosthetic material rather than a device intended to treat or cure a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" states that the device is an acrylic resin used as a permanent hard relining/pickup material for dentures. There is no information to suggest it is used for diagnosing any condition.
No
The intended use describes a physical material (acrylic resin) used for dentures, indicating a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "permanent hard relining / pickup material for complete and partial dentures." This is a material used on a medical device (dentures) and applied directly to the patient's mouth.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside the body to diagnose diseases or conditions. The description of SECURE does not involve any such testing of specimens.
Therefore, SECURE is a dental material used in the fabrication or repair of dentures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SECURE is an acrylic resin used as a permanent hard relining / pickup material for complete and partial 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
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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 logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2002
Mr. J. Brad Vance Director of Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401
Re: K021586
Trade/Device Name: SECURE Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: May 08, 2002 Received: May 14, 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 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. J. Brad Vance
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 (OS) 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 Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Patina Circuit/fa
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
KO21586 510 (K) Number (if known):
SECURE Device Name:
Indications For Use:
SECURE is an acrylic resin used as a permanent hard relining / pickup material for complete and partial dentures.
(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)
Susa Runses
(Division Sign-Off)
Division of Dental, Infection Control,
Owision of Dental, Infection Control, and General Hospital Devic 12001: 510(k) Number
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