(88 days)
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No
The document describes dental restorative materials and their indications for use. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The listed indications for use, such as fillings, core build-ups, and repair of restorations, describe materials used in dentistry for restorative purposes, not for treating diseases or improving health conditions in a therapeutic sense beyond structural repair.
No
The device is a restorative material used for fillings, core build-ups, and repairs of teeth, which are therapeutic and reconstructive functions, not diagnostic ones.
No
The provided text describes dental restorative materials, which are physical substances used in dental procedures. There is no mention of software, algorithms, or digital processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of these BRIGHT Restorative Materials is for direct application to teeth for fillings, core build-ups, splinting, and repairs. This is a direct treatment/restoration of a part of the body, not an examination of a specimen taken from the body.
- The indications for use describe dental procedures. The listed indications are all related to dental restorative and reconstructive procedures performed directly on the patient's teeth.
- There is no mention of analyzing biological samples. The description and intended use do not involve the analysis of blood, urine, tissue, or any other biological specimen.
Therefore, these BRIGHT Restorative Materials are considered medical devices used for dental treatment, not IVDs.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
EBF, 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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Konstantinos Kyritsis, PH.D. Research and Development Manager DMP. Limited Kalyvion Avenue Markopoulo Industrial Zone Attiki, 19003 GREECE
Re: K121915
Trade/Device Name: Bright Restorative Materials (Nanocream-Bright Flow, Bright Flow Core, Bright Heavy Core, Bright Light, Bright Light Flow, and Bright Posterior
Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, EBC Dated: May 28, 2012 Received: July 2, 2012
Dear Dr. Kyritsis:
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.
SEP 2 8 2012
1
Page 2 - Dr. Kyritsis
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. 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 yours,
Ph 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
510(k) Number (if known): K121915
Device Name: BRIGHT Restorative Materials, to include:
- NANOCERAM BRIGHT FLOW .
- BRIGHT FLOW CORE .
- BRIGHT HEAVY CORE .
- BRIGHT LIGHT .
- BRIGHT LIGHT FLOW .
- · BRIGHT POSTERIOR
Indications for Use:
NANOCERAM - BRIGHT FLOW
Indications for use:
- · Fillings of minimally invasive cavities of all classes
- Fillings of small class I cavities .
- Fillings of class II-V cavities including V-shaped defects and cervical caries
- Extended fissure sealing �
- Cavity lining as the first layer for Class I and II restorations
- Splinting of mobile teeth ●
- Blocking out of undercuts
- Small restorations of all types
- Repair of composite restorations and ceramic veneers
BRIGHT FLOW CORE - BRIGHT HEAVY CORE
Indications for use:
- Core build up of vital and non-vital teeth .
- Post cementation
3
BRIGHT LIGHT - BRIGHT LIGHT FLOW
BRIGHT LIGHT
Indications for use:
- Class I-V restorations .
- Reconstruction of affected anterior teeth ●
- Veneering of discoloured anterior teeth .
- Splinting of mobile teeth
- Repair of composite and ceramic veneers
BRIGHT LIGHT FLOW
Indications for use:
- · Fillings of minimally invasive cavities of all classes
- Fillings of class II-V cavities including V-shaped defects and cervical caries .
- Extended fissure sealing .
- Splinting of mobile teeth .
- Blocking out of undercuts .
- Small restorations of all types .
- Repair of composite restorations and ceramic veneers
BRIGHT POSTERIOR
Indications for use:
- · Direct posterior restorations (Class I and II), including occlusal surfaces
- Core build ups ●
- Splinting of mobile teeth
Prescription Use . X (21 CFR Part 801 Subpart D) AND/OR
. Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| Page 2 of 2 | |
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| 510(k) Number: | K121915 |