(74 days)
K#961284, K#072746, K#080940
Not Found
No
The 510(k) summary describes a dental resin material and its physical properties, with no mention of AI or ML technology in its intended use, device description, or performance studies.
No.
The device is a tooth shade resin material used for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, which is not a therapeutic function.
No
The device is a resin material used for masking discolorations and making individualized shade characterizations in dental restorations. It is a treatment material, not a diagnostic one.
No
The device description clearly states it is a paste packaged in a syringe and contains physical materials like silica zirconia and silica-titania filler, 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:
- Intended Use: The intended use is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations. This is a direct application to the tooth for aesthetic and restorative purposes.
- Device Description: The device is a low viscosity light-cured tint applied to the tooth.
- Lack of In Vitro Testing: The description of performance studies focuses on physical properties like depth of cure and color stability, which are relevant to the material's performance in a dental restoration, not diagnostic testing of a biological sample.
- No Mention of Biological Samples: There is no indication that this device is used to test or analyze biological samples (like blood, urine, tissue, etc.), which is a core characteristic of IVDs.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ESTELITE COLOR tooth shade resin material is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.
Product codes
EBF
Device Description
ESTELITE COLOR is a low viscosity light-cured tint for individualized shade characterizations. The device comes in a paste, packaged in a syringe. The device contains silica zirconia and silica-titania filler. All ingredients have been cleared for use by the FDA in similar devices.
The device does not come sterilized and is not intended to be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing of the physical properties of the ESTELITE COLOR device, including depth of cure and color stability after irradiation, were conducted in accordance with ISO4049:2009. There were no clinical tests performed for the ESTELITE COLOR device. Based on the non-clinical testing conducted of the physical properties of the ESTELITE COLOR device in comparison to the KOLOR+ tooth shade resin material predicate device (K#961284) as described above, it is concluded that the ESTELITE COLOR device is as safe, as effective, and performs as well as or better than KOLOR+ device.
Key Metrics
Not Found
Predicate Device(s)
K#961284, K#072746, K#080940
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(k) Summary Tokuyama Dental Corporation ESTELITE COLOR K#110178
APR - 5 2011
The following information is provided pursuant to 21 CFR 807.92.
807.92(a)(1)
(i) 510(k) Submitter
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
March 15, 2011
807.92(a)(2)
Trade or Proprietary Name: Common Name: Classification Name: Product Code:
ESTELITE COLOR tooth shade resin material material, tooth shade, resin EBF
1
807.92(a)(3)
The ESTELITE COLOR device is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices. Specifically, for purposes of performance characteristics the device is substantially equivalent to Sybron Dental's KOLOR+ tooth shade resin material (K#961284), and for purposes of biocompatibility the device is substantially equivalent to Tokuyama's own E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material (K#072746) and Tokuyama's own ESTELITE SIGMA OUICK tooth shade resin material (K#080940).
807.92(a)(4)
ESTELITE COLOR is a low viscosity light-cured tint for individualized shade characterizations. The device comes in a paste, packaged in a syringe. The device contains silica zirconia and silica-titania filler. All ingredients have been cleared for use by the FDA in similar devices.
Biocompatibility testing is not required because (i) all the ingredients in the ESTELITE COLOR device have already been authorized by the FDA for use in similar devices. (ii) the ESTELITE COLOR device is applied in small amounts below or in between layers of the composite restoration and is cured once applied, (iii) it is believed that no or almost no leaching of the ingredients occurs, and (iv) Tokuyama Dental Corporation has received no reports of any adverse incidents involving the ingredients used in the ESTELITE COLOR device except for extremely rare allergic reactions that affect one person approximately every two years.
The device does not come sterilized and is not intended to be sterilized prior to use.
807.92(a)(5)
The ESTELITE COLOR device is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.
807.92(a)(6)
The ESTELITE COLOR device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate devices identified above. The ESTELITE COLOR device does not have an energy source.
2
2
Specifically, for purposes of design the device has the same basic characteristics as Sybron Dental's KOLOR+ tooth shade resin material (K#961284), as both devices are light-cured color modifiers to be used under or between layers of the composite restoration. For purposes of material and chemical composition, the ESTELITE COLOR device has the same basic characteristics as Tokuyama's own E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material (K#072746) and Tokuyama's own ESTELITE SIGMA QUICK tooth shade resin materia! (K#080940), as the ingredients in the ESTELITE COLOR device are already authorized by the FDA for use in these two other devices.
807.92(b)(1)
Non-clinical testing of the physical properties of the ESTELITE COLOR device, including depth of cure and color stability after irradiation, were conducted in accordance with ISO4049:2009.
807.92(b)(2)
· There were no clinical tests performed for the ESTELITE COLOR device.
807.92(b)(3)
Based on the non-clinical testing conducted of the physical properties of the ESTELITE COLOR device in comparison to the KOLOR+ tooth shade resin material predicate device (K#961284) as described above, it is concluded that the ESTELITE COLOR device is as safe, as effective, and performs as well as or better than KOLOR+ device.
40712879.doc
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tokuyama Dental Corporation C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11th Floor Washington, DC 20005
APR - 5 2011
Re: K110178
Trade/Device Name: ESTELITE COLOR Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated; January 20, 2011 Received: January 21, 2011
Dear Mr. Barritt:
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.
4
Page 2- Mr. Barritt
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,
Wh.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
5
Indications for Use
K 110178
510(k) Number (if known):
ESTELITE COLOR Device Name:
. Indications For Use:
The ESTELITE COLOR tooth shade resin material is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suarez
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dentai Devices
510(k) Number: K110178
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