(41 days)
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No
The summary describes a dental restorative material (composite) and its intended uses, with no mention of AI or ML technology.
No
The device is a dental restorative material used for direct placement in various dental applications, such as filling cavities and repairing teeth. These functions are primarily reconstructive and cosmetic, not aimed at treating or preventing a disease or condition in a therapeutic sense.
No
Explanation: The "Intended Use / Indications for Use" section describes Metamorphosis as a material for repairing teeth and dental restorations, and for various dental procedures like filling cavities, acting as a base/liner, or cementing veneers. These are all restorative and material-based applications, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition or disease.
No
The device description clearly states "Metamorphosis, a nanohybrid composite, is a light-cured, resin-based, dental restorative designed for direct placement," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that Metamorphosis is a "light-cured, resin-based, dental restorative designed for direct placement" in teeth. Its intended uses are all related to restoring or repairing dental structures within the mouth.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, Metamorphosis is a dental restorative material used directly on the patient's teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.
Product codes
EBF, EBC
Device Description
Metamorphosis, a nanohybrid composite, is a light-cured, resin-based, dental restorative designed for direct placement.
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
anterior and posterior teeth
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)
Not Found
Reference Device(s)
Herculite Ultra, Premise Flowable
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/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a serif font.
MAY 2 1 2009
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: April 2009
Device Name:
- · Trade Name -- Metamorphosis
- · Common Name Dental Composite Restorative Material
- · Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690
Devices for Which Substantial Equivalence is Claimed:
- · Herculite Ultra, Kerr Corporation
- · Premise Flowable, Kerr Corporation
Device Description:
Metamorphosis, a nanohybrid composite, is a light-cured, resin-based, dental restorative designed for direct placement.
Intended Use of the Device:
Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.
Substantial Equivalence:
Metamorphosis is substantially equivalent to other legally marketed devices in the United States. Metamorphosis functions in a manner similar to Herculite Ultra and Premise Flowable, all currently marketed by Kerr Corporation.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY 21 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kerr Corporation C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K091023
Trade/Device Name: Metamorphosis Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC Dated: April 8, 2009 Received: April 10, 2009
Dear Ms. Garman:
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 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.
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. Garman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Runar
Susan Runar, D.D.S., M.A.
Susan Runner, D.D.S., MA Acting 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
510(k) Number (if known): K 09 1023
Device Name: Metamorphosis
Indications For Use:
Metamorphosis is intended for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, cement for ceramic / composite veneers, core buildups and incisal abrasions.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSR.
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091023
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