(243 days)
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.
The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.
OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the OMNICHROMA FLOW tooth shade resin material.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Physical Property) | Reported Device Performance (OMNICHROMA FLOW) | Predicate Device (OMNICHROMA) Performance | Reference Device (ESTELITE UNIVERSAL FLOW) Performance |
|---|---|---|---|
| Sensitivity to ambient light | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Depth of cure | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Flexural strength | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Water sorption | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Solubility | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Color stability | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Radio-opacity | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Shelf life | 3 years at 0-25°C (32-77Fº) | 3 years at 0-25°C (32-77Fº) | 3 years at 0-25°C (32-77Fº) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each physical property test. It mentions that "Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, 'Dentistry -- Polymer-based Restorative Materials.'" The ISO standard would define the required sample sizes for each test.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or for Tokuyama Dental Corporation, a Japanese company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a "tooth shade resin material," and its performance is evaluated against engineering standards (ISO 4049) and biocompatibility, not by expert interpretation of images or clinical outcomes that would require ground truth established by medical experts like radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study involves physical property testing against an engineering standard, not clinical adjudication of diagnoses or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a dental restorative material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical material, not an algorithm. The performance testing was of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the physical property testing is based on the requirements and methodologies outlined in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials," which are standardized engineering and material science criteria. For biocompatibility, the ground truth is established by standard biological evaluation methods (cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing).
8. The sample size for the training set
This information is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reason stated in point 8.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 19, 2020
Tokuyama Dental Corporation % Keith Barritt Official Correspondent Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, District of Columbia 20024
Re: K193537
Trade/Device Name: Omnichroma Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: Mav 21, 2020 Received: May 22, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Srinivas "Nandu" Nandkumar Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193537
Device Name OMNICHROMA FLOW
Indications for Use (Describe)
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and 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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510(k) Summary Tokuyama Dental Corporation OMNICHROMA FLOW tooth shade 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. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
August 14, 2020
Device
| Trade or Proprietary Name: | OMNICHROMA FLOW |
|---|---|
| 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 OMNICHROMA (K#173275) Reference Device: Tokuyama Dental Corporation's ESTELITE UNIVERSAL FLOW (K#180613)
Device Description
The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.
OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
Indications for Use
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite.
Comparison of Technological Characteristics
The OMNICHROMA FLOW device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate device identified above, as each device is a tooth shade resin material that is cured by photo polymerization. The OMNICHROMA FLOW device does not have its own energy source.
For purposes of performance characteristics for obtaining FDA marketing authorization, the OMNICHROMA FLOW device is substantially equivalent to Tokuyama's own primary predicate, the OMNICHROMA device (K#173275), as shown below:
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| Subject device | Primary predicate | Reference | Difference | ||||
|---|---|---|---|---|---|---|---|
| Device name | OMNICHROMAFLOW | OMNICHROMA | ESTELITE UNIVERSALFLOW | ||||
| Manufacturer | Tokuyama Dental | Tokuyama Dental | Tokuyama Dental | ||||
| 510(k) No. | K193537(Pending) | K173275 | K180613 | - | |||
| Health Canada licence No. | 101564 | 101263 | |||||
| Classification name | Material, ToothShade, Resin | Material, Tooth Shade,Resin | Material, Tooth Shade,Resin | - | |||
| Indications for Use | - Direct anterior andposterior restorations- Cavity base or liner- Repair ofporcelain/composite | For use as a tooth shaderesin material in dentalprocedures, such as:- Direct anterior andposterior restorations- Direct bondedcomposite veneer- Diastema closure- Repair ofporcelain/composite | - Direct anterior andposterior restorations- Cavity base or liner- Blocking out cavityundercuts beforefabricating indirectrestorations- Repair ofporcelain/composite | SimilarThe indications forUse of subject deviceis within that of thepredicate andreference devices. | |||
| Component | Container | Syringeor Pre-loadedtip | Syringe or Pre-loadedtip | Syringe or Pre-loadedtip | Identical | ||
| Shade | 1 shade | 1 shade | 12 shade | SimilarThe number of shadesof the subject deviceis within that of thepredicate andreference devices. | |||
| Principle of operation | Tooth shade resinmaterial that is curedby photopolymerization.(Light-cure) | Tooth shade resinmaterial that is cured byphoto polymerization.(Light-cure) | Tooth shade resinmaterial that is cured byphoto polymerization.(Light-cure) | Identical | |||
| Material | Filler | - Silica-zirconia filler- Composite filler | - Silica-zirconia filler- Composite filler | - Silica-zirconia filler- Composite filler | SimilarThe subject deviceconsists mainly of | ||
| Resinmatrixmonomer | - 1,6-bis(methacryl-ethyloxycarbonylamino)trimethyl hexane (UDMA)- Nonamethylenedioldimethacrylate (ND) | - 1,6-bis(methacryl-ethyloxycarbonylamino)trimethyl hexane (UDMA)- Triethylene glycoldimethacrylate(TEGDMA) | - Bisphenol A polyethoxymethacrylate (Bis-MPEPP)- Bisphenol A di(2-hydroxypropoxy)dimethacrylate (Bis-GMA)- Triethylene glycoldimethacrylate(TEGDMA)- 1,6-bis(methacryl-ethyloxycarbonylamino)trimethyl hexane (UDMA) | fillers andmethacrylates as withthe predicate andreference devices.The biocompatibilityof the device has beenthoroughly evaluatedand performancetested. | |||
| Physicalproperty | Sensitivityto ambientlight | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Similar but alldevices conform tothe requirements ofISO 4049 and | ||
| Depth ofcure | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | therefore thesubjected device is | |||
| Flexuralstrength | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | substantiallyequivalent. |
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| Watersorption | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | ||
|---|---|---|---|---|---|
| Solubility | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | ||
| Colorstability | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | ||
| Radio-opacity | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | ||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical | |
| Shelf life | 3 years at atemperature between0-25°C (32-77Fº) | 3 years at a temperaturebetween0-25°C (32-77Fº) | 3 years at a temperaturebetween0-25°C (32-77Fº) | Identical |
Shelf Life Testing
Tokuyama tested the device to establish a shelf life of three years at a temperature between 0-25°C (32-77F°).
Material And Chemical Composition
The device does come into direct contact with the patient.
For purposes of material and chemical composition, the OMNICHROMA FLOW device has the same basic characteristics as Tokuyama's own OMNICHROMA (K#173275) and ESTELITE UNIVERSAL FLOW (K#180613).
Additional biocompatibility assessment included cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing.
Performance Data Summary
Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW device.
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| Subject device | Primary predicate | Reference | Difference | ||
|---|---|---|---|---|---|
| Device name | OMNICHROMAFLOW | OMNICHROMA | ESTELITE UNIVERSALFLOW | - | |
| Physicalproperty | Sensitivityto ambientlight | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | Similar but alldevicesconform to therequirements ofISO 4049 andtherefore thesubjecteddevice issubstantiallyequivalent. |
| Depth ofcure | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Flexuralstrength | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Watersorption | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Solubility | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Colorstability | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Radio-opacity | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO4049 | Conformed to therequirement of ISO 4049 | ||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical | |
| Shelf life | 3 years at atemperature between0-25°C (32-77F°) | 3 years at a temperaturebetween0-25°C (32-77F°) | 3 years at a temperaturebetween0-25°C (32-77F°) | Identical |
Comparison of OMNICHROMA FLOW device with the primary predicate and reference device:
Conclusion
Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA FLOW device in comparison to the predicate device identified above, and based on the biocompatibility of authorized devices with similar ingredients for the same use and additional biocompatibility testing, it is concluded that the OMNICHROMA FLOW device is substantially equivalent to the predicate device.
41429091.doc
§ 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.