(52 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and anatomical sites.
No
The device is used for sealing and filling, which are preventive and restorative procedures, not therapeutic ones aimed at treating or curing a disease.
No
The device, Grandio Seal, is described as intended for "sealing/filling of pits and fissures" and "sealing/facing of damaged enamel surfaces," among other sealing functions. These are preventative or restorative actions, not diagnostic ones. It does not mention identifying, analyzing, or predicting a condition.
No
The provided 510(k) summary does not contain enough information to determine if the device is software-only. The "Device Description" section is missing, which is crucial for understanding the nature of the device and whether it includes hardware components. The intended use describes a material (sealant/filling) being applied, which strongly suggests a physical product, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being applied directly to teeth and enamel surfaces within the mouth for sealing and filling purposes. This is an in vivo application (within a living organism).
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
The description of Grandio Seal's use clearly falls outside the definition of an IVD. It's a dental material used for direct application to teeth.
N/A
Intended Use / Indications for Use
Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.
Product codes
EBC
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
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
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Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT == 2 2006
Dr. Michael Sues Mgr. for Regulatory Affairs Voco GmbH Anton-Flettner-St. 1-3 Cuxhaven, GERMANY D-27472
Re: K062344
Trade/Device Name: Grandio Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: August 7, 2006 Received: August 11, 2006
Dear Dr. Sues:
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 - Dr. Sues
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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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Indications for Use Statement
510(k) Number: _
Device Name: Grandio Seal
Indications for Use:
Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged
composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.
Prescription Use __X
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punson
: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------of Anasmesiology, General Hospital, n Control, Dental Devices
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