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K Number
K180613
Device Name
Estelite Universal Flow
Manufacturer
Tokuyama Dental Corporation
Date Cleared
2018-07-12

(126 days)

Product Code
EBFEST
Regulation Number
872.3690
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESTELITE UNIVERSAL FLOW device is indicated 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 Description
The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time. ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm. The device does not come sterilized and is not intended to be sterilized prior to use.
More Information

K161353

K080940, K051808

No
The document describes a dental resin material and its physical properties, with no mention of AI or ML technology.

No.

Explanation: A therapeutic device is used to treat or cure a disease or condition. This device is a restorative material used for dental procedures, which is generally considered a repair or reconstruction activity rather than a therapeutic treatment.

No

Explanation: The device is a dental restorative material (tooth shade resin) used for direct restorations, cavity bases, and repairs. Its function is to fill or repair teeth, not to diagnose conditions.

No

The device description clearly states it is a light-cured, radiopaque composite resin material, which is a physical substance, not software.

Based on the provided information, the ESTELITE UNIVERSAL FLOW device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's a "tooth shade resin material in dental procedures" for direct restorations, cavity bases, blocking undercuts, and repairing porcelain/composite. These are all procedures performed directly on the patient's tooth.
  • Device Description: The description details a light-cured composite resin for use in anterior and posterior restorations. This further reinforces its use within the mouth.
  • Anatomical Site: The anatomical site is listed as "Tooth," which is part of the human body, not a sample taken from the body.
  • Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health condition based on those samples.

IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ESTELITE UNIVERSAL FLOW device is used in vivo (within the living body) for restorative dental procedures.

N/A

Intended Use / Indications for Use

The ESTELITE UNIVERSAL FLOW device is indicated 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

Product codes

EBF

Device Description

The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time.

ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.

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 ESTELITE UNIVERSAL FLOW device was conducted in accordance with ISO 4049:2009, "Dentistry --Polymer-based Restorative Materials." There were no clinical tests performed for the ESTELITE UNIVERSAL FLOW device.

Key results: Each device conforms to the requirements of ISO 4049 and therefore the ESTELITE UNIVERSAL FLOW device is substantially equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161353

Reference Device(s)

K080940, K051808

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

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

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

Re: K180613

Trade/Device Name: Estelite Universal Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material. Regulatory Class: Class II Product Code: EBF Dated: May 30, 2018 Received: June 5, 2018

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.

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

July 12, 2018

1

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 comprehensive regulatory information about medical devices and radiation-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,

Mary S. Runner -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

2

EXHIBIT 11

3

Indications for Use

510(k) Number (if known)

Device Name ESTELITE UNIVERSAL FLOW

Indications for Use (Describe)

The ESTELITE UNIVERSAL FLOW device is indicated 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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4

510(k) Summary Tokuyama Dental Corporation ESTELITE UNIVERSAL 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. 901 15th Street, N.W., Suite 700 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com

(ii) Preparation Date

May 30, 2018

Device

Trade or Proprietary Name: Common Name: Classification Name: Class: Product Code:

ESTELITE UNIVERSAL FLOW tooth shade resin material material, tooth shade, resin 2 EBF

5

Predicate Device

Primary Predicate: Tokuyama Dental Corporation's ESTELITE BULK FILL Flow (K#161353).

Reference Devices: Tokuyama Dental Corporation's ESTELITE SIGMA QUICK (K#080940), and Tokuyama Dental Corporation's ESTELITE FLOW QUICK (K#051808).

Device Description

The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time.

ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.

The device does not come sterilized and is not intended to be sterilized prior to use.

Indications for Use

The ESTELITE UNIVERSAL FLOW device is indicated 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 ESTELITE UNIVERSAL 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 ESTELITE UNIVERSAL FLOW device does not have its own energy source.

6

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

Subject devicePrimary predicateDifference
Device nameESTELITE UNIVERSAL FLOWESTELITE BULK FILL Flow
ManufacturerTokuyama DentalTokuyama Dental
510(k) No.(Pending)K161353
Classification nameMaterial, Tooth Shade, ResinMaterial, Tooth Shade, Resin
Indications for UseFor 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 | For use as a tooth shade resin
    material in dental procedures, such
    as:
  • Direct anterior and posterior
    restorations
  • Cavity lining
  • Blocking out cavity undercuts before
    fabricating indirect restorations
  • Repair of porcelain/composite | The indications for Use of subject
    device is essentially the same as
    predicate device. |
    | 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-zirconia filler
    · Composite filler | The subject device consists mainly of
    fillers and methacrylates as with the |
    | | Resin
    matrix
    monomer | | - Bisphenol A polyethoxy
    methacrylate (Bis-MPEPP)
  • Bisphenol A di(2-
    hydroxypropoxy) dimethacrylate
    (Bis-GMA)
  • Triethylene glycol
    dimethacrylate (TEGDMA)
  • 1,6-bis(methacryl-ethyloxy
    carbonylamino)trimethyl hexane
    (UDMA) | - Bisphenol A polyethoxy
    methacrylate (Bis-MPEPP)
  • Bisphenol A di(2-
    hydroxypropoxy) dimethacrylate
    (Bis-GMA)
  • Triethylene glycol dimethacrylate
    (TEGDMA) | predicate device.
    Since all of the ingredients to be used in
    the subject device have already been
    used in such existing devices as Estelite
    Sigma Quick (K080940), Estelite Flow
    Quick (K051808) and Estelite Bulk Fill
    Flow (K161353), the safety of subject
    device is assured. |
    | Physical | property | Sensitivity
    to ambient
    light | Conformed to the requirement of
    ISO 4049 Dentistry -- Polymer-
    based restorative materials | Conformed to the requirement of
    ISO 4049 Dentistry -- Polymer-
    based restorative materials | Each device conforms to the
    requirements of ISO 4049 and
    therefore the ESTELITE
    UNIVERSAL FLOW device is
    substantially equivalent. |
    | | | 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 | |
    | | Shade | | 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 | |

Comparison of ESTELITE UNIVERSAL FLOW device with the primary predicate

7

| | Radio-
opacity | Conformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials | Conformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials | |
|---------------|-------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--|
| Sterilization | | Non-sterile | Non-sterile | |
| Shelf life | | 3 years at a temperature between
0-25°C (32-77F°) | 3 years at a temperature between
0-25°C (32-77F°) | |

Shelf Life Testing

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

Material And Chemical Composition

For purposes of material and chemical composition, the ESTELITE UNIVERSAL FLOW device has the same basic characteristics as Tokuyama's own ESTELITE BULK FILL Flow (K#161353), ESTELITE SIGMA QUICK (K#080940), and ESTELITE FLOW QUICK (K#051808).

Performance Data Summary

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

The device does come into direct contact with the patient. The ingredients in the ESTELITE UNIVERSAL FLOW device are the same as in three of Tokuyama's own previously authorized devices, namely ESTELITE BULK FILL Flow (K#161353), ESTELITE SIGMA OUICK (K#080940), and ESTELITE FLOW QUICK (K#051808). These devices have been used for many years without any reportable incidents to local health authorities and for which almost no complaints have been received regarding personal adverse effects of any kind and no serious injuries. Thus, under Section 6 of ISO 10993-1, no further biocompatibility testing is required.

8

Comparison of Performance Data of ESTELITE UNIVERSAL FLOW device with the primary predicate

Device nameSubject devicePrimary predicateDifference
510(k) No.ESTELITE UNIVERSAL FLOW
(Pending)ESTELITE BULK FILL Flow
K161353
Physical
propertySensitivity
to ambient
lightConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsEach device conforms to the
requirements of ISO 4049 and
therefore the ESTELITE
UNIVERSAL FLOW device is
substantially equivalent.
Depth of
cureConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
Flexural
strengthConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
Water
sorptionConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
SolubilityConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
ShadeConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
Color
stabilityConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
Radio-
opacityConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materialsConformed to the requirement of
ISO 4049 Dentistry -- Polymer-
based restorative materials
SterilizationNon-sterileNon-sterile
Shelf life3 years at a temperature between
0-25°C (32-77F°)3 years at a temperature between
0-25°C (32-77F°)

Conclusion

Based on the non-clinical testing conducted of the physical properties of the ESTELITE UNIVERSAL FLOW 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 ESTELITE UNIVERSAL FLOW device is substantially equivalent to the predicate device.

41334960.doc