OMNICHROMA

K173275 · Tokuyama Dental Corporation · EBF · Feb 27, 2018 · Dental

Device Facts

• Record ID: K173275
• Device Name: OMNICHROMA
• Applicant: Tokuyama Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Feb 27, 2018
• 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 - Direct bonded composite veneer - Diastema closure - Repair of porcelain/composite

Device Story

OMNICHROMA is a light-cured, radiopaque composite resin used by dentists for direct anterior and posterior restorations. The device is supplied in a single shade, eliminating the need for shade matching. It is applied by the clinician into the cavity or onto the tooth surface and cured via photo-polymerization using a dental curing light. The material serves as a restorative agent to repair carious lesions, close diastemas, or bond veneers. By providing a single-shade solution that conforms to ISO 4049 standards, it simplifies the restorative workflow for the practitioner and provides a functional, aesthetic tooth-colored restoration for the patient.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing of physical properties in accordance with ISO 4049:2009, including depth of cure, flexural strength, water sorption, solubility, color stability, and radiopacity.

Technological Characteristics

Light-cured, radiopaque composite resin. Materials: Silica-zirconia filler, composite filler, UDMA, and TEGDMA monomers. Form factor: Syringe or pre-loaded tip. Energy source: External dental curing light (photo-polymerization). Conforms to ISO 4049:2009 standards for polymer-based restorative materials. Non-sterile.

Indications for Use

Indicated for dental patients requiring direct anterior and posterior restorations, direct bonded composite veneers, diastema closures, or repair of porcelain/composite restorations.

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

• Palfique Estelite LV Clear (K010267)

Reference Devices

• CLEARFIL MAJESTY ES-2 (K121583)
• VENUS PEARL (K112501)
• ESTELITE SIGMA QUICK (K080940)
• ESTELITE FLOW QUICK (K051808)
• ESTELITE BULK FILL FLOW (K161353)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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: [phone]

# (ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 901 15th Street, Suite 700 Washington, DC 20005 [phone] Phone: Facsimile: [phone] [e-mail] 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,<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>- Direct bonded composite<br>veneer<br>- Diastema closure<br>- Repair of<br>porcelain/composite | For use as a tooth shade<br>resin material in dental<br>procedures. | Indications for<br>new device are<br>within those of<br>the predicate |
| Component | Container | Syringe or Pre-loaded tip | Syringe | Use of pre-loaded<br>tip |
| | Shade | 1 shade | 1 shade | - |
| Principle of operation | | Tooth shade resin material<br>that is cured by photo<br>polymerization. (Light-<br>cure) | Tooth shade resin material<br>that is cured by photo<br>polymerization. (Light-<br>cure) | - |
| Material | Filler | - Silica-zirconia filler<br>- Composite filler | - Silica-titania filler | As all of the<br>ingredients in the<br>subject device<br>have already<br>been authorized<br>by FDA for use<br>in similar devices |
| | Resin matrix monomer | - 1,6-bis(methacryl-<br>ethyloxy<br>carbonylamino)trimethyl<br>hexane (UDMA)<br>- Triethylene glycol<br>dimethacrylate<br>(TEGDMA) | - Methacrylates | |
| Physical property | Sensitivity to ambient light | Conformed to the<br>requirement of ISO 4049 | Conformed to the<br>requirement of ISO 4049 | Conformance to<br>standard; specific<br>measurements<br>may vary slightly |
| | Depth of cure | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | |
| | Flexural strength | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | |
| | Water sorption | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | |
| | Solubility | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | |
| | Color stability | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | |
| | Radio- opacity | Conformed to the<br>requirement of ISO 4049<br>Dentistry -- Polymer-<br>based restorative materials | - | |
| Sterilization | | Non-sterile | Non-sterile | |

# Comparison of OMNICHROMA device with the primary predicate device

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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.

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