Who is the manufacturer of Omnichroma Flow?

Tokuyama Dental Corporation filed the 510(k) submission for Omnichroma Flow (K193537).

What is the FDA product code for Omnichroma Flow?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Omnichroma Flow?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Omnichroma Flow?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Omnichroma Flow

K193537 · Tokuyama Dental Corporation · EBF · Aug 19, 2020 · Dental

Device Facts

Record ID	K193537
Device Name	Omnichroma Flow
Applicant	Tokuyama Dental Corporation
Product Code	EBF · Dental
Decision Date	Aug 19, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite.

Device Story

OMNICHROMA FLOW is a low-viscosity, light-cured, radiopaque composite resin paste supplied in 1.8mL plastic syringes. Used by licensed healthcare professionals in dental clinics for direct anterior and posterior restorations, cavity lining, and repair of porcelain or composite structures. The material is cured extra-orally using a halogen or LED curing-light (400-500 nm). The single-shade composite simplifies restorative procedures by eliminating shade selection. The device is non-sterile and intended for single-patient use. Benefits include ease of handling and clinical versatility in restorative dentistry.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing of physical properties (sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, color stability, and radiopacity) in accordance with ISO 4049:2009, alongside biocompatibility testing.

Technological Characteristics

Low-viscosity, light-cured, radiopaque composite resin. Materials: silica-zirconia filler, composite filler, UDMA, and ND monomers. Dimensions: 1.8mL syringe. Energy source: external halogen or LED curing-light (400-500 nm). Non-sterile. Shelf life: 3 years (0-25°C). Conforms to ISO 4049:2009.

Indications for Use

Indicated for direct anterior and posterior dental restorations, cavity base or liner, and repair of porcelain/composite materials. Contraindicated for patients with allergies or hypersensitivity to methacrylic monomers, UV absorbers, or other ingredients.

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

OMNICHROMA (K173275)

Reference Devices

ESTELITE UNIVERSAL FLOW (K180613)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 | {4}------------------------------------------------ ## 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: {5}------------------------------------------------ | | | Subject device | | Primary predicate | Reference | Difference | | |---------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Device name | | OMNICHROMA FLOW | | OMNICHROMA | ESTELITE UNIVERSAL FLOW | | | | Manufacturer | | Tokuyama Dental | | Tokuyama Dental | Tokuyama Dental | | | | 510(k) No. | | K193537 (Pending) | | K173275 | K180613 | - | | | Health Canada licence No. | | | | 101564 | 101263 | | | | Classification name | | Material, Tooth Shade, Resin | | Material, Tooth Shade, Resin | Material, Tooth Shade, Resin | - | | | Indications for Use | | - Direct anterior and posterior restorations - Cavity base or liner - Repair of porcelain/composite | | 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 | - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite | Similar The indications for Use of subject device is within that of the predicate and reference devices. | | | Component | | Container | Syringe or Pre- loaded tip | Syringe or Pre-loaded tip | Syringe or Pre-loaded tip | Identical | | | | | Shade | 1 shade | 1 shade | 12 shade | Similar The number of shades of the subject device is within that of the predicate and reference devices. | | | 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) | Tooth shade resin material that is cured by photo polymerization. (Light-cure) | Identical | | | Material | | Filler | - Silica-zirconia filler - Composite filler | - Silica-zirconia filler - Composite filler | - Silica-zirconia filler - Composite filler | Similar The subject device consists mainly of | | | | | Resin matrix monomer | - 1,6-bis(methacryl- ethyloxy carbonylamino)trimet hyl hexane (UDMA) - Nonamethylenediol dimethacrylate (ND) | - 1,6-bis(methacryl- ethyloxy carbonylamino)trimethy l hexane (UDMA) - Triethylene glycol dimethacrylate (TEGDMA) | - Bisphenol A polyethoxy methacrylate (Bis- MPEPP) - Bisphenol A di(2- hydroxypropoxy) dimethacrylate (Bis- GMA) - Triethylene glycol dimethacrylate (TEGDMA) - 1,6-bis(methacryl- ethyloxy carbonylamino)trimethy l hexane (UDMA) | fillers and methacrylates as with the predicate and reference devices. The biocompatibility of the device has been thoroughly evaluated and performance tested. | | | Physical property | 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 | Similar but all devices conform to the requirements of ISO 4049 and | | | | Depth of cure | | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | therefore the subjected device is | | | | Flexural strength | | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | Conformed to the requirement of ISO 4049 | substantially equivalent. | | {6}------------------------------------------------ | | 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 | Identical | | Shelf life | | 3 years at a temperature between 0-25°C (32-77Fº) | 3 years at a temperature between 0-25°C (32-77Fº) | 3 years at a temperature between 0-25°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. {7}------------------------------------------------ | | | Subject device | Primary predicate | Reference | Difference | |----------------------|------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | | OMNICHROMA FLOW | OMNICHROMA | ESTELITE UNIVERSAL FLOW | - | | Physical property | 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 | Similar but all devices conform to the requirements of ISO 4049 and therefore the subjected device is substantially equivalent. | | | 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 | Identical | | Shelf life | | 3 years at a temperature between 0-25°C (32-77F°) | 3 years at a temperature between 0-25°C (32-77F°) | 3 years at a temperature between 0-25°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

Omnichroma Flow

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Omnichroma Flow

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps