Who is the manufacturer of Estelite Universal Flow?

Tokuyama Dental Corporation filed the 510(k) submission for Estelite Universal Flow (K180613).

What is the FDA product code for Estelite Universal 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 Estelite Universal Flow?

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

Who can help prepare an FDA 510(k) submission like Estelite Universal 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.

Estelite Universal Flow

Q: What are the predicate devices for Estelite Universal Flow?

ESTELITE BULK FILL Flow (K161353).

K180613 · Tokuyama Dental Corporation · EBF · Jul 12, 2018 · Dental

Device Facts

Record ID	K180613
Device Name	Estelite Universal Flow
Applicant	Tokuyama Dental Corporation
Product Code	EBF · Dental
Decision Date	Jul 12, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2
Attributes	Therapeutic

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 Story

Light-cured, radiopaque composite resin for dental restorations. Incorporates Radical-Amplified Photopolymerization (RAP) technology for shortened curing time and extended working time. Available in three viscosities (High, Medium, Super Low) in syringes or pre-loaded tips. Used by dentists in clinical settings for direct anterior/posterior restorations, cavity lining, undercut blocking, and repair of porcelain/composite materials. Device is non-sterile. Clinician applies material to tooth structure, then uses external light source to initiate polymerization. Benefits include improved handling, aesthetic tooth-matching, and structural restoration of damaged teeth.

Clinical Evidence

Bench testing only. No clinical data performed. Physical properties (sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, shade, color stability, radiopacity) were tested and confirmed to meet ISO 4049:2009 standards.

Technological Characteristics

Light-cured composite resin. Materials: spherical silica-zirconia filler (100-300 nm), composite filler, and methacrylate monomers (Bis-MPEPP, Bis-GMA, TEGDMA, UDMA). RAP technology initiator. Non-sterile. Shelf life 3 years (0-25°C). Conforms to ISO 4049.

Indications for Use

Indicated for dental patients requiring direct anterior/posterior restorations, cavity base/liner, cavity undercut blocking, or porcelain/composite repair.

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)

Reference Devices

ESTELITE SIGMA QUICK (K080940)
ESTELITE FLOW QUICK (K051808)

Related Devices

K161353 — ESTELITE BULK FILL Flow · Tokuyama Dental Corporation · Apr 3, 2017
K182288 — TPH Spectra ST Flowable Composite Restorative · Dentsply Sirona · Nov 20, 2018
K964867 — HYBRID RESIN COMPOSITE · Parkell, Inc. · Apr 11, 1997
K193496 — CharmFil · Dentkist, Inc. · May 6, 2020
K201707 — Opallis, Opallis Flow · Dentscare Ltda · Dec 22, 2020

Submission Summary (Full Text)

{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) #### 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." {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 device | Primary predicate | Difference | |------------------------|----------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | | | ESTELITE UNIVERSAL FLOW | ESTELITE BULK FILL Flow | | | Manufacturer | | | Tokuyama Dental | Tokuyama Dental | | | 510(k) No. | | | (Pending) | K161353 | | | Classification name | | | Material, Tooth Shade, Resin | Material, Tooth Shade, Resin | | | 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 | 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 name | | Subject device | Primary predicate | Difference | |----------------------|------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | | ESTELITE UNIVERSAL FLOW (Pending) | ESTELITE BULK FILL Flow K161353 | | | 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 | | | | 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°) | | #### 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