Omnichroma Flow Bulk

K203598 · Tokuyama Dental Corporation · EBF · Feb 3, 2021 · Dental

Device Facts

• Record ID: K203598
• Device Name: Omnichroma Flow Bulk
• Applicant: Tokuyama Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Feb 3, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a tooth shade resin material in dental procedures such as: - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite

Device Story

OMNICHROMA FLOW BULK is a low-viscosity, light-cured, radiopaque composite resin for dental restorations. Used by licensed healthcare professionals in clinical settings; applied directly into prepared cavities in 3.5mm increments. Cured via halogen or LED light (400-500 nm). Material acts as a restorative filler; provides structural support and aesthetic tooth-shade matching. Benefits include simplified handling and bulk-fill capability for various carious classes.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated against ISO 4049:2009 standards for dentistry polymer-based restorative materials, including sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, color stability, and radiopacity.

Technological Characteristics

Low-viscosity, light-cured composite resin. Materials: silica-zirconia filler, composite filler, UDMA, TEGDMA, mequinol, dibutyl hydroxyl toluene, UV absorber. Curing: 400-500 nm halogen/LED. Form factor: syringe. Non-sterile. Conforms to ISO 4049:2009.

Indications for Use

Indicated for dental patients requiring direct anterior or posterior restorations, cavity base or liner placement, blocking out of cavity undercuts, or repair of porcelain/composite materials.

Regulatory Classification

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.

Predicate Devices

• ESTELITE BULK FILL Flow (K161353)
• OMNICHROMA FLOW (K193537)

Reference Devices

• ESTELITE UNIVERSAL FLOW High (K180613)
• OMNICHROMA (K173275)
• ESTELITE FLOW QUICK High Flow (K051808)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 3, 2021

Tokuyama Dental Corporation % Keith Baritt Correspondent Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, District of Columbia 20024

Re: K203598

Trade/Device Name: Omnichroma Flow Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 8, 2020 Received: December 9, 2020

Dear Keith Baritt:

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

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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) 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K203598

Device Name

OMNICHROMA FLOW BULK

Indications for Use (Describe)

For use as a tooth shade resin material in dental procedures such as:

- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K203598

# 510(k) Summary Tokuyama Dental Corporation OMNICHROMA FLOW BULK tooth shade resin material

#### Submitter

## (i) 510(k) Submitter

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: [phone]

## (ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 Phone: [phone] Facsimile: [phone] Email: [e-mail]

# (iii) Preparation Date

February 2, 2021

## Device

| Trade or Proprietary Name: | OMNICHROMA FLOW BULK |
|----------------------------|------------------------------|
| Common Name: | tooth shade resin material |
| Classification Name: | material, tooth shade, resin |
| Class: | 2 |
| Product Code: | EBF |

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# Predicate Device

| Primary Predicates: Tokuyama Dental Corp.'s ESTELITE BULK FILL Flow (K#161353) and<br>OMNICHROMA FLOW (K#193537) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices for Performance:<br>Tokuyama Dental Corp.'s ESTELITE UNIVERSAL FLOW High<br>(K#180613) |
| Additional Reference Devices for Biocompatibility:<br>Tokuyama Dental Corp.'s OMNICHROMA (K#173275) and<br>ESTELITE FLOW QUICK High Flow (K#051808) |

# Device Description

The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.

The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.

OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.

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.

# Indications for Use

For use as a tooth shade resin material in dental procedures such as:

- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite

# Comparison of Technological Characteristics

The OMNICHROMA FLOW BULK 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 BULK device does not have its own energy source.

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For purposes of performance characteristics for obtaining FDA marketing authorization, the OMNICHROMA FLOW BULK device is substantially equivalent to Tokuyama's own predicate devices, the ESTELITE BULK FILL Flow device (K#161353) and the OMNICHROMA FLOW (K#193537), as shown below:

| | | Subject device | Predicate #1 | Predicate #2 | Difference |
|---------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | | OMNICHROMA FLOW<br>BULK | ESTELITE BULK FILL<br>Flow | OMNICHROMA<br>FLOW | - |
| Manufacturer | | Tokuyama Dental | Tokuyama Dental | Tokuyama Dental | - |
| 510(k) No. | | K203598 | K161353 | K193537 | - |
| Health Canada licence No. | | (Pending) | 98095 | 104170 | - |
| Classification name | | Material, Tooth Shade,<br>Resin | Material, Tooth Shade,<br>Resin | Material, Tooth Shade,<br>Resin | - |
| Indications for Use | | For use as a tooth shade<br>resin material in dental<br>procedures such as:<br>- Direct anterior and<br>posterior restorations<br>- Cavity base or liner<br>- Blocking out cavity<br>undercuts before<br>fabricating indirect<br>restorations<br>- Repair of<br>porcelain/composite | For use as a tooth shade<br>resin material in dental<br>procedures such as:<br>- Direct anterior and<br>posterior restorations<br>- Cavity lining<br>- Blocking out cavity<br>undercuts before<br>fabricating indirect<br>restorations<br>- Repair of<br>porcelain/composite | - Direct anterior and<br>posterior<br>restorations<br>- Cavity base or liner<br>- Repair of<br>porcelain/composite | Similar<br>The indications<br>for Use of subject<br>device is within<br>that of the<br>predicate and<br>reference devices. |
| Component | Container | Syringe | Syringe or Pre-loaded tip | Syringe | Similar<br>The container<br>type of subject<br>device is within<br>that of the<br>predicate and<br>reference devices. |
| | Shade | 1 shade | 4 shades | 1 shade | Similar<br>The number of<br>shade of subject<br>device is within<br>that of the<br>predicate and<br>reference devices. |
| Principle of operation | | Tooth shade resin material<br>that is cured by photo<br>polymerization. (Light-cure) | Tooth shade resin<br>material that is cured by<br>photo polymerization.<br>(Light-cure) | Tooth shade resin<br>material that is cured<br>by photo<br>polymerization.<br>(Light-cure) | Identical |
| Material | Filler | - Silica-zirconia filler<br>-Composite filler | - Silica-zirconia filler<br>- Composite filler | - Silica-zirconia filler<br>- Composite filler | Similar<br>The subject<br>device consists<br>mainly of fillers<br>and methacrylates<br>as with the<br>predicate and<br>reference devices.<br>The<br>biocompatibility<br>of the device has<br>been thoroughly<br>evaluated and<br>performance<br>tested. |
| | Resin matrix<br>monomer | -1,6-bis(methacryl-ethyloxy<br>carbonylamino)trimethyl<br>hexane (UDMA)<br>-Triethylene glycol<br>dimethacrylate<br>(TEGDMA) | - Bisphenol A di(2-<br>hydroxypropoxy)<br>dimethacrylate (Bis-<br>GMA)<br>- Bisphenol A<br>polyethoxy<br>methacrylate (Bis-<br>MPEPP)<br>- Triethylene glycol<br>dimethacrylate<br>(TEGDMA) | -1,6-bis(methacryl-<br>ethyloxy<br>carbonylamino)trimet<br>hyl hexane (UDMA)<br>-Nonamethylenediol<br>dimethacrylate (ND) | |
| Physical<br>property | Sensitivity to<br>ambient light | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | Similar but all<br>devices conform<br>to the<br>requirements of<br>ISO 4049 and<br>therefore the |
| | Depth of cure | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | requirements of<br>ISO 4049 and<br>therefore the |
| | Flexural<br>strength | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | subjected device<br>is substantially<br>equivalent. |
| | Water<br>sorption | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | |
| | Solubility | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | |
| | Color<br>stability | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | |
| | Radio-<br>opacity | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO<br>4049 | |
| Sterilization | | Non-sterile | Non-sterile | Non-sterile | Identical |
| Shelf life | | 3 years at a temperature<br>between<br>0.25°C (32.77F°) | 3 years at a temperature<br>between<br>0.25°C (32.77F°) | 3 years at a<br>temperature between<br>0.25°C (32.77F°) | Identical |

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# Shelf Life Testing

Tokuyama tested the device to establish a shelf life of three years at a temperature between 0-25°C (32-77F°).

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## Material And Chemical Composition

The device does come into direct contact with the patient. However, all of the ingredients contained in OMNICHROMA FLOW BULK are used in Tokuyama Dental Corp.'s OMNICHROMA (K#173275), OMNICHROMA FLOW (K#193537), and ESTELITE FLOW QUICK High Flow (K#051808).

## Performance Data Summary

Non-clinical testing of the physical properties of the OMNICHROMA FLOW BULK device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW BULK device.

A comparison of the OMNICHROMA FLOW BULK device with the predicate devices shown below:

| | | Subject device | Predicate #1 | Predicate #2 | Difference |
|----------------------|---------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | | OMNICHROMA FLOW<br>BULK | ESTELITE BULK FILL<br>Flow | OMNICHROMA FLOW | - |
| Physical<br>property | Sensitivity to<br>ambient light | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Similar but all<br>devices conform<br>to the<br>requirements of<br>ISO 4049 and<br>therefore the<br>subjected device<br>is substantially<br>equivalent. |
| | Depth of cure | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| | Flexural<br>strength | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| | Water<br>sorption | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| | Solubility | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| | Color<br>stability | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| | Radio-<br>opacity | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | |
| Sterilization | | Non-sterile | Non-sterile | Non-sterile | Identical |
| Shelf life | | 3 years at a temperature<br>between<br>0-25°C (32-77F°) | 3 years at a temperature<br>between<br>0-25°C (32-77F°) | 3 years at a<br>temperature between<br>0-25°C (32-77F°) | Identical |

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# Conclusion

Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA FLOW BULK 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 BULK device is substantially equivalent to the predicate devices.