(12 days)
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Not Found
No
The 510(k) summary describes dental composite materials and their intended uses, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The devices are restorative materials used for direct restorations of teeth and repairs of crowns/bridges, which are not considered therapeutic devices.
No
Explanation: The device is described as a composite material used for direct restorations and repairs of teeth, which are treatment procedures, not diagnostic ones.
No
The provided text describes dental composite materials, which are physical substances used for restorations. There is no mention of software or digital components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (direct restorations, diastema closures, intraoral repairs, cavity base/liner) are all procedures performed directly on the patient's teeth within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to diagnose a condition, monitor treatment, or screen for diseases.
- Anatomical Site: The anatomical site is listed as "anterior or posterior teeth," which are parts of the living body, not samples taken from the body.
IVD devices are specifically designed for testing biological samples in vitro (outside the living organism). The Nuance Universal, Posterior, and Flowable Composites are materials used in vivo (within the living organism) for dental restorations.
N/A
Intended Use / Indications for Use
Nuance Universal Composite:
- Direct restorations of anterior or posterior teeth (Class I Class V) .
- Diastema closures .
- Intraoral repairs of fractured crowns/bridges ●
Nuance Posterior Composite:
- Direct restorations of Class I and Class II cavities .
Nuance Flowable Composite:
- Direct restorations of anterior or posterior teeth .
- Cavity base/liner .
- Intraoral repairs of fractured crowns/bridges .
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
anterior or 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 (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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Discus Dental, LLC C/O Mr. Casey Conry Responsible Third Party official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
MAY 1 2 2010
Re: K101215
Trade/Device Names: Nuance Universal Composite, Nuance Posterior Composite, and Nuance Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 28, 2010 Received: April 30, 2010
Dear Mr. Conry:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Mr. Conry
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); 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nn for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number:
Device Name: Nuance Dental Composite Material
Indications For Use:
Nuance Universal Composite:
- Direct restorations of anterior or posterior teeth (Class I Class V) .
- Diastema closures .
- Intraoral repairs of fractured crowns/bridges ●
Nuance Posterior Composite:
-
Direct restorations of Class I and Class II cavities .
Nuance Flowable Composite: -
Direct restorations of anterior or posterior teeth .
-
Cavity base/liner .
-
Intraoral repairs of fractured crowns/bridges .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) | ||
| Kei Muliy for MSR | |||
| (Division Sign-Off) | |||
| Division of Anesthesiology, General Hospital | |||
| Infection Control, Dental Devices | |||
| 10(k) Number: | K101215 |