(65 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use describes a dental restorative material, which does not inherently require AI/ML.
No
The provided text describes a dental restorative material used for fillings, veneers, and splinting, which are reparative or cosmetic procedures, not typically considered therapeutic in the sense of treating a disease or disorder.
No
The provided text describes the intended use of a dental material (likely a composite or restorative resin) for various types of dental restorations and repairs, which are treatment procedures rather than diagnostic ones.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes applications for dental restorations, which typically involve physical materials and procedures, making it unclear if the device is solely software for planning, analysis, or other non-physical functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental restorations and procedures performed on the patient's teeth (anterior and posterior restorations, veneers, splinting, repairs, inlays/onlays). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Being used in a laboratory setting
The device appears to be a dental restorative material or system used directly in the mouth for treating dental issues.
N/A
Intended Use / Indications for Use
4 Seasons is intended to be used for:
- Anterior restorations (Classes III, IV) .
- . Class V restorations (cervical caries, root erosion, wedged-shaped defects)
- . Restorations in the posterior region (Classes I and II)
- Veneering of discolored anterior teeth .
- Splinting of mobile teeth
- Preventitive resin restorations in molars and premolars
- Repair of composite and ceramic veneers
- Inlays/Onlays with extra-oral post-tempering.
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): 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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§ 872.3690 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Ms. Donna Marie Hartnett, Esq. Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K024094
Trade/Device Name: 4 Seasons® Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 09, 2002 Received: December 11, 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 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 - Ms. Donna Marie Hartnett, Esq.
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 (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) you may obtain. 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,
Susan Russo
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
KO24094 510(k) Number (if known): Ronding
Device Name:
4 Seasons
Indications For Use:
4 Seasons is intended to be used for:
- Anterior restorations (Classes III, IV) .
- . Class V restorations (cervical caries, root erosion, wedged-shaped defects)
- . Restorations in the posterior region (Classes I and II)
- Veneering of discolored anterior teeth .
- Splinting of mobile teeth
- Preventitive resin restorations in molars and premolars
- Repair of composite and ceramic veneers
- Inlays/Onlays with extra-oral post-tempering.
(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)
Over-The-Counter Use
Kein Mulay for MSR (Optional Format 1-2-96)
(Division Sign-Off) ision of Anesthesiology, General Hospital, Infection Control, Dental Devices
OR
510(k) Number. K024094