TKO Composite Bite Turbo Gel

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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. July 20, 2021 Reliance Orthodontic Products, Inc % Brian Dean Biomedical Engineering Consultant Cook Device Solutions 7640 Delaine Ct Indianapolis, Indiana 46254 Re: K210349 Trade/Device Name: TKO Composite Bite Turbo Gel Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 23, 2021 Received: June 24, 2021 Dear Brian Dean: 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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # SECTION 6.0 #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) #### K210349 Device Name TKO Composite Bite Turbo Gel Indications for Use (Describe) TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ SECTION 5.0 - 510 (k) Summary Image /page/3/Picture/1 description: The image contains the logo for Reliance Orthodontic Products. The logo consists of a stylized letter "R" enclosed in a circle on the left, followed by the word "RELIANCE" in bold, uppercase letters. Below "RELIANCE" are the words "ORTHODONTIC PRODUCTS" in a smaller, non-bold font. Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com ### 1. Submitter Information: Date of 510(k) Summary: 6/23/2021 Submitter: Reliance Orthodontics Products Inc. Preparer and Contact Name: Brian Dean, BME Consultant 510(k) Owner: Paul Gange, President Address: 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: 630-773-4009 / Fax: 630-250-7704 Email: bdean@cookds.com Email: pgange@relianceorthodontics.com #### Device Name and Classification: 2. | Common Name of Device: | Orthodontic Light Cure Dental Resin | |--------------------------|-------------------------------------| | Device Proprietary Name: | TKO Composite Bite Turbo Gel | | Classification Panel: | Dental | | Classification Number: | 872.3690 | | Classification Name: | Tooth shade resin material | | Class: | II | | Product Code: | EBF | | 510(k) Number: | K210349 | ### 3. Substantial Equivalence: Legally marketed devices to with equivalence is claimed: - Primary predicate: Ortho Bite 510(k) K192682 - . Reference: Triad Orthodontic Gel 510(k) K882482 ### 4. Device Description Intended for use in the creation of occlusal buildups (bite turbos) and as a retainer repair composite. It bonds to enamel, porcelain, acrylic and metal for duration of treatment externally communicating device that contacts tissue/bone/dentin. TKO Composite Bite Turbo Gel is dispensed from a precision 3.5 gm LuerLoc syringe with tips. ### 5. Indications for Use and Population: TKO Composite Bite Turbo Gel is intended for use as a flowable light cure composite gel for the Intended Use: creation of occlusal buildups (bite turbos) and as a retainer repair composite. Diseases/Conditions for diagnosis, treatment, prevention, cure, or mitigation: None Population: Orthodontic or Dental Office ### 6. Predicate Devices: - Ortho Bite 510(k) K192682 is similar in intended use, handling and technology compared to the device described a. in this submission. - b. Triad Orthodontic Gel 510(k) K882482 dated 08/12/1988 is similar in intended use, handling and technology compared to the device described in this submission. - Comparison of Technological Characteristics with the predicate devices: C. {4}------------------------------------------------ # SECTION 5.0 – 510 (k) Summary Image /page/4/Picture/1 description: The image shows the logo for Reliance Orthodontic Products. The logo consists of a stylized letter "R" enclosed in a circle on the left. To the right of the logo are the words "RELIANCE" in a bold, sans-serif font, with the words "ORTHODONTIC PRODUCTS" in a smaller font below. **PRODUCTS** Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com | | Phone: (630) 773-4009 Website: www.relianceorthodontics.com | | | |-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission | Reliance Orthodontics<br>K210349 | Dentscare Ltda<br>K192682 | Dentsply International<br>K882482 | | Model | TKO Composite Bite Turbo<br>Gel | Ortho Bite™ | Triad Orthodontic Gel | | Classification | Class II, EBF,<br>21CFR872.3690 | Class II, EBF, 21CFR872.3690 | Class II, EBI,<br>21CFR872.3760 | | Intended Use | TKO is a pink, flowable light<br>cure composite gel for the<br>creation of occlusal buildups<br>(bite turbos) and as a retainer<br>repair composite. | The product is indicated for<br>cementing orthodontic bands and is<br>also suitable for temporary dental<br>disocclusion during orthodontic<br>treatment. | Triad Gel Material is a<br>visible light cure material<br>indicated for the<br>fabrication of functional<br>orthodontic appliances,<br>repairs, relines and<br>rebases. | | Device<br>Description | Intended for use in the<br>creation of occlusal buildups<br>(bite turbos) and as a retainer<br>repair composite. It bonds to<br>enamel, porcelain, acrylic and<br>metal for duration of<br>treatment. It is categorized as<br>a permanent externally<br>communicating device that<br>contacts tissue/bone/dentin. | Ortho Bite is a light-curing self-<br>adhesive composite with self-<br>levelling characteristics and surface<br>hardness. The product is colored in<br>order to facilitate its identification<br>during application and removal. | Triad Gel Material is<br>suitable where materials<br>with high flow<br>characteristics are<br>desired, such as when<br>encapsulating and<br>retaining orthodontic<br>wires, mesh, etc. Triad<br>Gel Material contains no<br>methyl methacrylate<br>monomer. | | Chemical<br>Composition | Urethane Dimethacrylate<br>Triethylene Glycol<br>Dimethacrylate<br>Hexafunctional Urethane<br>Acrylate Oligomer<br>2-Ethyl-4-<br>dimethylaminobenzoate<br>Camphorquinone<br>FD&C Red #40 | The adhesives contain methacrylate<br>as resin fillers and silica that is used<br>as fillers. Its composition includes<br>dimethacrylate monomers, HEMA<br>Phosphate, traditional<br>Camphorquinone/DABE system as<br>photoinitiator and silica as load<br>particle. The combination of silica<br>load fillers with the dimethacrylate<br>monomer composition results in a<br>viscosity that allows it to be handled<br>and applied without running off the<br>application area. The presence of<br>HEMA Phosphate allows adhesion<br>to the enamel surface, which is a<br>known feature of composite cements<br>indicated for bracket bonding. The<br>thixotropy allows the product to have<br>self-levelling capability, known as a<br>shear thinning property that makes<br>the composite settle correctly on the<br>occlusal surface. | 80-100% Proprietary<br>Aliphatic Urethane<br>Methacrylate<br>1-10% Amorphous<br>Precipitated Silica | | Submission | Reliance Orthodontics<br>K210349 | Dentscare Ltda<br>K192682 | Dentsply International<br>K882482 | | Dispensing | Precision syringe (3.5 gm) | Syringe (4 g) | Squeeze tube (22 gm) | | Sterilization | Non-Sterile | Non-Sterile | Non-Sterile | | Shelf-Life | 24 months at room<br>temperature | 36 months at 5° to 27°C | 24 months at < 75 °F | | Method of<br>Cure | Light cure for 20 seconds<br>from close range with a dental<br>curing light of 1000 mW or<br>more. | Light cure. Data on time to cure not<br>available at time of submission. | Light cure at variable<br>times from 30 sec to 3<br>minutes per use case. | | Color | Pink | Blue<br>Colorless (UV Trace) | Clear, colorless<br>Clear, blue<br>Clear, pink<br>Clear, red | {5}------------------------------------------------ ## SECTION 5.0 - 510 (k) Summary Image /page/5/Picture/1 description: The image contains the logo for Reliance Orthodontic. The logo consists of a stylized letter "R" enclosed in a circle on the left, followed by the word "RELIANCE" in bold, uppercase letters. Below "RELIANCE" is the word "ORTHODONTIC" in smaller, uppercase letters. The logo is simple and professional, with a focus on the company name. **PRODUCTS** Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca. IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com # i. Summary of the different technological characteristics of the subject devices compared to the predicate and reference devices Despite the indications for use statement for TKO being not identical to the predicates in that the predicate device includes additional indication of bonding of tubes and wording is slightly different; the differences do not alter the intended use of the device relative to the predicate, since all devices have the same intended use, that is to be used as a bonding agent for orthodontic appliances. Regarding the indication for temporary dental disocclusion during orthodontic treatment, that is an additional and exclusive indication to the predicate device Ortho Bite. The use of these materials is a common method to create mini-bite plane in daily orthodontic practice. The subject device is similar to the predicate devices in that they are all light-curing resin cements to be used for cementation of orthodontic pieces. The subject device and the predicate devices have substantially equivalent indications for use, shelf life, physical, technological and mechanical properties. All products, including the reference device, meet the same recognized standards. The subject devices are slightly different from the predicate and reference devices, in that they contain the same key biocompatible ingredients, but in different proportions. The primary difference between TKO. Triad Gel, and Ortho Bite is the method of dispensation where TKO and Ortho Bite utilize a syringe. ### ii. Non-Clinical Data Submitted TKO Composite Bite Turbo Gel was tested against physical parameter requirements of the Triad Orthodontic Gel by Dentsply International and compared with the Dentscare Ltda Ortho Bite. The following performance data were provided in support of the substantial equivalence determination where all elements were found to be compliant: | Characteristic | Test Method | Unit | Requirement<br>(High<br>Performance /<br>Critical Area) | Test Result | |-------------------------------|-------------|------|---------------------------------------------------------|----------------------| | Shear Bond Strength<br>Enamel | RD-022 | MPa | 5 sample average ≥ 8 | Pass<br>16.47 ± 4.24 | {6}------------------------------------------------ # SECTION 5.0 - 510 (k) Summary Image /page/6/Picture/1 description: The image shows the logo for Reliance Orthodontic Products. The logo consists of a stylized letter "R" enclosed in a circle on the left. To the right of the circle is the word "RELIANCE" in a bold, sans-serif font, and below that is the text "ORTHODONTIC PRODUCTS" in a smaller font. Reliance Orthodontic Products Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA Phone: (630) 773-4009 | Website: www.relianceorthodontics.com | Shear Bond Strength<br>Steel | RD-022 | MPa | 5 sample average ≥ 8 | Pass<br>36.157 ± 1.37 | |------------------------------------|--------------------------------------------|-------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------| | Shear Bond Strength<br>Porcelain | RD-022 | MPa | 5 sample average ≥ 8 | Pass<br>21.54 ± 5.12 | | Shear Bond Strength<br>Acrylic | RD-022 | MPa | 5 sample average ≥ 8 | Pass<br>24.28 ± 3.57 | | Flexural Strength<br>ISO-4049:2019 | ISO-4049:2019 | MPa | 4 of 5 samples ≥ 80 | Pass<br>5 of 5 samples > 80 | | Hardness after Cure | QC-006 | N/mm2 | > 69 Top<br>> 67 Bottom<br>After 20 s L/C | Pass<br>>69 Top<br>> 67 Bottom | | Depth of Cure | ISO 4049:2019 | mm | 3 of 3 samples ≥ 1.5 | Pass<br>3 of 3 samples > 1.5 | | Sensitivity to Ambient<br>Light | ISO 4049:2019 | Homogeno<br>us visual<br>inspection | 3 of 3 samples | Pass<br>3 of 3 samples<br>homogenous | | Water Sorption | ISO 4049:2019 | ug/mm3 | 4 of 5 < 40 | Pass<br>5 of 5 < 40 | | Water Solubility | ISO 4049:2019 | ug/mm3 | 4 of 5 < 7.5 | Pass<br>5 of 5 < 7.5 | | Biocompatibility | ISO 10993-5<br>ISO 7405:2018 | N/A | Passes Cytotoxicity<br>or Oral Toxicity<br>testing | Pass<br>14 day oral toxicity | | Storage and Shelf Life | Stability study for<br>3.7 months at 50 °C | N/A | SBS. Flexural<br>Strength, and<br>Hardness after cure<br>pass after cure | Pass<br>24 month shelf life at room<br>temperature. | | Packaging | RD-037 | N/A | Passes suitability<br>testing | Pass | ### iii. Conclusions Clinical testing was determined to be unnecessary with the approval of all non-clinical testing. Based on the nonclinical testing conducted and equivalency in characteristics demonstrated between Reliance TKO, Dentscare Ltda Ortho Bite, and Dentsply International Triad Gel devices. In conjunction with biocompatibility demonstrated via ISO 7405 and ISO 10993-5 evaluations, evidence has been submitted to demonstrate Reliance TKO is substantially equivalent to the predicate device in biocompatibility and equivalent to or better than the predicate devices in terms of performance against its intended use.