(280 days)
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No
The document describes a dental material (SR Ivocron) and its various preparation techniques for dental restorations. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device, SR Ivocron, is described for use in dental procedures like temporaries, securing ground denture teeth, and crowns/bridges, which are restorative or prosthetic applications, not therapeutic.
No
The provided text describes the intended use of SR Ivocron, a material used for dental temporaries, repairs, crowns, and bridges. These are restorative and fabrication processes, not diagnostic procedures used to identify or determine the nature of a disease or condition.
No
The provided text describes a material (SR Ivocron) and techniques for its use in dental applications (temporaries, repairs, crowns, bridges). It does not describe any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described (temporaries, securing denture teeth, repair of PMMA, crowns, bridges) are all related to dental procedures performed directly on or in the patient's mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests outside the body on biological samples to gain information about a person's health. This device's function is clearly related to creating or repairing dental prosthetics and restorations used within the body.
N/A
Intended Use / Indications for Use
Cold technique: With the Cold Liquid, SR Ivocron may be used for temporaries, securing ground denture teeth, and repair of PMMA.
Hot technique: When used with the Hot Liguid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR Ivocron must be layered over a metal framework.
Press (flasking) technique: For the press technique, SR Ivocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.
Product codes
EBG, EBF
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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Image /page/0/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The words "HUMAN SERVICES • USA" and "DEPARTMENT" are arranged in a circular pattern around the top and bottom of the image, respectively.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K013869
Trade/Device Name: SR Ivocron Regulation Number: 872.3770 and 872.3690 Regulation Name: Temporary Crown, Bridge Resin and Tooth Shade Resin Material Regulatory Class: II Product Code: EBG and EBF Dated: May 28, 2002 Received: May 30, 2002
Dear Ms. Hartnett:
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 controle Existing major regulations affecting vour 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.
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Page 2 - Ms. Hartnett
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
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510(k) Number (if known): K013869
Device Name:
SR Ivocron
Indications For Use:
Cold technique: With the Cold Liquid, SR Ivocron may be used for temporaries, securing ground denture teeth, and repair of PMMA.
Hot technique: When used with the Hot Liguid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR lvocron must be layered over a metal framework.
Press (flasking) technique: For the press technique, SR Ivocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-C
Division of Anesthesiology. General Hospital, Intection Control. Der
510(k) Number: