(138 days)
No
The summary describes a composite resin material for dental restorations and does not mention any AI or ML components or functionalities.
No.
The device is a restorative material for dental procedures, not a device intended to treat or cure a disease or condition.
No
The device is described as a light-cured, radiopaque composite resin for use in dental restorations, not for diagnosing conditions. Its intended use is to repair teeth and is not related to identifying or characterizing diseases or conditions.
No
The device is described as a light-cured, radiopaque composite resin, which 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 direct dental restorations and procedures performed on the tooth, within the mouth.
- Device Description: It's a composite resin material used for filling cavities and restoring teeth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside the body to diagnose a condition, monitor treatment, or screen for diseases.
- Anatomical Site: The anatomical site is teeth, which are part of the body, not a sample being tested.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a restorative material used directly on the patient's teeth.
N/A
Intended Use / Indications for Use
For use as a tooth shade resin material in dental procedures, such as:
- Direct anterior and posterior restorations
- Direct bonded composite veneer
- Diastema closure
- Repair of porcelain/composite
Product codes
EBF
Device Description
The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing of the physical properties of the OMNICHROMA device was conducted in accordance with ISO 4049:2009. which specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
There were no clinical tests performed for the OMNICHROMA device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K121583, K112501, K080940, K051808, K161353
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
February 27, 2018
Tokuyama Dental Corporation % Keith Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington, District of Columbia 20005
Re: K173275
Trade/Device Name: OMNICHROMA Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 28, 2017 Received: November 29, 2017
Dear Keith 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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K173275
Device Name
OMNICHROMA
Indications for Use (Describe)
For use as a tooth shade resin material in dental procedures, such as:
- Direct anterior and posterior restorations
- Direct bonded composite veneer
- Diastema closure
- Repair of porcelain/composite
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K173275
510(k) Summary Tokuyama Dental Corporation OMNICHROMA dental resin material
Submitter
(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. 901 15th Street, Suite 700 Washington, DC 20005 (202) 783-5070 Phone: Facsimile: (202) 783-2331 barritt@fr.com Email:
(iii) Preparation Date
February 26, 2018
De vice
| Trade or Proprietary Name: | OMNICHROMA |
|---|---|
| Common Name: | tooth shade resin material |
| Classification Name: | material, tooth shade, resin |
| Class: | 2 |
| Product Code: | EBF |
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Predicate Device
Primary Predicate: Tokuyama Dental Corporation's PALFIQUE ESTELITE LV CLEAR (K#010267).
Reference Devices: Kuraray's CLEARFIL MAJESTY ES-2 (K#121583); Heraeus Kulzer's VENUS PEARL (K#112501); Tokuyama Dental Corporation's ESTELITE SIGMA QUICK (K#080940); Tokuyama Dental Corporation's ESTELITE FLOW QUICK (K#051808); and Tokuyama Dental Corporation's ESTELITE BULK FILL FLOW (K#161353)
De vice Description
The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.
The device does not come sterilized and is not intended to be sterilized prior to use.
Indications for Use
For use as a tooth shade resin material in dental procedures, such as:
- Direct anterior and posterior restorations
- Direct bonded composite veneer
- Diastema closure
- Repair of porcelain/composite
Comparison of Technological Characteristics
The OMNICHROMA device does not have its own energy source. There are no accessories provide with the device. The OMNICHROMA device has the same basic technological characteristics in terms of design, material, and chemical composition as the primary predicate device as shown below:
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| Subject device | Primary predicate | Difference | ||
|---|---|---|---|---|
| Device name | OMNICHROMA | Palfique Estelite LV Clear | - | |
| Manufacturer | Tokuyama Dental | Tokuyama Dental | - | |
| 510(k) No. | K173275 | K010267 | - | |
| Classification name | Material, Tooth Shade, | |||
| Resin | Material, Tooth Shade, | |||
| Resin | - | |||
| Indications for Use | For use as a tooth shade | |||
| resin material in dental | ||||
| procedures, such as: |
- Direct anterior and
posterior restorations - Direct bonded composite
veneer - Diastema closure
- Repair of
porcelain/composite | For use as a tooth shade
resin material in dental
procedures. | Indications for
new device are
within those of
the predicate |
| Component | Container | Syringe or Pre-loaded tip | Syringe | Use of pre-loaded
tip |
| | Shade | 1 shade | 1 shade | - |
| Principle of operation | | Tooth shade resin material
that is cured by photo
polymerization. (Light-
cure) | Tooth shade resin material
that is cured by photo
polymerization. (Light-
cure) | - |
| Material | Filler | - Silica-zirconia filler - Composite filler | - Silica-titania filler | As all of the
ingredients in the
subject device
have already
been authorized
by FDA for use
in similar devices |
| | Resin matrix monomer | - 1,6-bis(methacryl-
ethyloxy
carbonylamino)trimethyl
hexane (UDMA) - Triethylene glycol
dimethacrylate
(TEGDMA) | - Methacrylates | |
| Physical property | Sensitivity to ambient light | Conformed to the
requirement of ISO 4049 | Conformed to the
requirement of ISO 4049 | Conformance to
standard; specific
measurements
may vary slightly |
| | Depth of cure | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | |
| | Flexural strength | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | |
| | Water sorption | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | |
| | Solubility | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | |
| | Color stability | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | |
| | Radio- opacity | Conformed to the
requirement of ISO 4049
Dentistry -- Polymer-
based restorative materials | - | |
| Sterilization | | Non-sterile | Non-sterile | |
Comparison of OMNICHROMA device with the primary predicate device
6
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Performance Data Summary
Non-clinical testing of the physical properties of the OMNICHROMA device was conducted in accordance with ISO 4049:2009. which specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting. The polymer-based luting materials covered by ISO 4049:2009 are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
There were no clinical tests performed for the OMNICHROMA device.
Conclusion
Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA device in comparison to the predicate device identified above, and on the biocompatibility of authorized devices for the same use with the same ingredients, it is concluded that the OMNICHROMA device is substantially equivalent to the predicate device.
41318781.doc