(97 days)
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No
The 510(k) summary describes a dental material (core build-up and post cementation) 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 material for core build-ups and cementation of posts, which is a dental material and not a device intended to treat or prevent a disease or condition.
No
The device is described as being for "core build-ups and cementation of posts," which are restorative dental procedures, not diagnostic ones.
No
The provided text describes a dental material (core build-up and cementation of posts) and does not mention any software component.
Based on the provided information, the ParaPost ParaCore automix 5ml is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for core build-ups and cementation of posts." This describes a dental procedure performed directly on a patient's tooth, not a test performed on a sample taken from the 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 biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the ParaPost ParaCore automix 5ml is a dental material used in a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts
Product codes
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 9
Coltene/Whaledent AG C/O Mr. II.J. Vogelstein Consultant Henry J. Vogelstein 1349 Lexington Avenue New York, New York 10128
Re: K052820
Trade/Device Name: ParaPost ParaCore Automix 5ml Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 9, 2005 Received: December 12, 2005
Dear Mr. Vogelstein:
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. Vogelstein
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), 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/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
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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Coltène/Whaledent AG 510(k) Submission ParaPost ParaCore automix 5ml Indications for use
Indications for use
Kosz8zo 510(k) Number (if known): n/k
Device Name:
ParaPost ParaCore automix 5ml
Indications for use:
- ParaPost ParaCore automix 5ml is indicated for core build-ups and cementation of posts
X Prescription Use: _ (21 CFR Part 801 Subpart D)
Over-the Counter Use: _ (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
and/or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punner
Sydney General Hosp
Edwards, Lifesci Devices