(162 days)
TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar composite.
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.
The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "TKO Composite Bite Turbo Gel." It outlines the device's characteristics, intended use, and a comparison with legally marketed predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Important Note: This document pertains to a medical device (dental resin) and not an AI/ML enabled device. Therefore, many of the requested criteria related to AI/ML device performance (e.g., MRMC studies, training set details, expert ground truth adjudication) are not applicable and thus not present in the document. The study described focuses on non-clinical, physical, and chemical performance testing to demonstrate substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Test Method | Unit | Acceptance Criteria (Requirement) | Reported Device Performance (Test Result) |
|---|---|---|---|---|
| Shear Bond Strength (Enamel) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (16.47 ± 4.24) |
| Shear Bond Strength (Steel) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (36.157 ± 1.37) |
| Shear Bond Strength (Porcelain) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (21.54 ± 5.12) |
| Shear Bond Strength (Acrylic) | RD-022 | MPa | 5 sample average ≥ 8 | Pass (24.28 ± 3.57) |
| Flexural Strength | ISO-4049:2019 | MPa | 4 of 5 samples ≥ 80 | Pass (5 of 5 samples > 80) |
| Hardness after Cure | QC-006 | N/mm² | > 69 Top, > 67 Bottom (After 20 s L/C) | Pass (>69 Top, > 67 Bottom) |
| Depth of Cure | ISO 4049:2019 | mm | 3 of 3 samples ≥ 1.5 | Pass (3 of 3 samples > 1.5) |
| Sensitivity to Ambient Light | ISO 4049:2019 | Homogeneous visual inspection | 3 of 3 samples (homogenous) | Pass (3 of 3 samples homogenous) |
| Water Sorption | ISO 4049:2019 | µg/mm³ | 4 of 5 < 40 | Pass (5 of 5 < 40) |
| Water Solubility | ISO 4049:2019 | µg/mm³ | 4 of 5 < 7.5 | Pass (5 of 5 < 7.5) |
| Biocompatibility | ISO 10993-5, ISO 7405:2018 | N/A | Passes Cytotoxicity or Oral Toxicity testing | Pass (14 day oral toxicity) |
| Storage and Shelf Life | Stability study for 3.7 months at 50 °C | N/A | SBS, Flexural Strength, and Hardness after cure pass after cure | Pass (24 month shelf life at room temperature) |
| Packaging | RD-037 | N/A | Passes suitability testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes: The sample sizes are specified for individual tests:
- Shear Bond Strength: 5 samples per test (for enamel, steel, porcelain, acrylic)
- Flexural Strength: 5 samples
- Hardness after Cure: Not explicitly stated, implied to be at least 2 (top/bottom)
- Depth of Cure: 3 samples
- Sensitivity to Ambient Light: 3 samples
- Water Sorption: 5 samples
- Water Solubility: 5 samples
- Biocompatibility: Not explicitly stated for number of samples, but mentions "14 day oral toxicity" which implies in vivo or in vitro testing.
- Storage and Shelf Life: Not explicitly stated for number of samples, but refers to a "stability study."
- Packaging: Not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It describes "non-clinical data submitted" and "performance data provided in support of the substantial equivalence determination." These are likely lab-based experimental studies conducted by or for the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- This information is not applicable to this type of device and study. The "ground truth" here is established by standardized test methods (e.g., ISO standards, internal RD and QC procedures) and the objective measurement of physical and chemical properties, not by expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes where there might be disagreement among evaluators. Here, the results are quantitative measurements from lab tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- This information is not applicable. An MRMC study is relevant for evaluating the performance of AI/ML systems in conjunction with human readers, typically in image interpretation. This document describes a physical dental material, not an AI/ML device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This question pertains to AI/ML algorithm performance. The device is a dental material, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is defined by established physical and chemical standards and test methodologies. For example:
- Shear Bond Strength is measured according to method RD-022.
- Flexural Strength, Depth of Cure, Water Sorption, and Water Solubility are measured according to ISO 4049:2019.
- Hardness after Cure is measured according to QC-006.
- Biocompatibility is assessed against ISO 10993-5 and ISO 7405:2018.
- The ground truth is not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather on the quantitative results derived from these standardized tests, which are then compared to pre-defined acceptance criteria.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable. As it's not an AI/ML device, there is no training set or ground truth established for it in that context.
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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
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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
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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)
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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:
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.
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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 OrthodonticsK210349 | Dentscare LtdaK192682 | Dentsply InternationalK882482 |
| Model | TKO Composite Bite TurboGel | Ortho Bite™ | Triad Orthodontic Gel |
| Classification | Class II, EBF,21CFR872.3690 | Class II, EBF, 21CFR872.3690 | Class II, EBI,21CFR872.3760 |
| Intended Use | TKO is a pink, flowable lightcure composite gel for thecreation of occlusal buildups(bite turbos) and as a retainerrepair composite. | The product is indicated forcementing orthodontic bands and isalso suitable for temporary dentaldisocclusion during orthodontictreatment. | Triad Gel Material is avisible light cure materialindicated for thefabrication of functionalorthodontic appliances,repairs, relines andrebases. |
| DeviceDescription | Intended for use in thecreation of occlusal buildups(bite turbos) and as a retainerrepair composite. It bonds toenamel, porcelain, acrylic andmetal for duration oftreatment. It is categorized asa permanent externallycommunicating device thatcontacts tissue/bone/dentin. | Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surfacehardness. The product is colored inorder to facilitate its identificationduring application and removal. | Triad Gel Material issuitable where materialswith high flowcharacteristics aredesired, such as whenencapsulating andretaining orthodonticwires, mesh, etc. TriadGel Material contains nomethyl methacrylatemonomer. |
| ChemicalComposition | Urethane DimethacrylateTriethylene GlycolDimethacrylateHexafunctional UrethaneAcrylate Oligomer2-Ethyl-4-dimethylaminobenzoateCamphorquinoneFD&C Red #40 | The adhesives contain methacrylateas resin fillers and silica that is usedas fillers. Its composition includesdimethacrylate monomers, HEMAPhosphate, traditionalCamphorquinone/DABE system asphotoinitiator and silica as loadparticle. The combination of silicaload fillers with the dimethacrylatemonomer composition results in aviscosity that allows it to be handledand applied without running off theapplication area. The presence ofHEMA Phosphate allows adhesionto the enamel surface, which is aknown feature of composite cementsindicated for bracket bonding. Thethixotropy allows the product to haveself-levelling capability, known as ashear thinning property that makesthe composite settle correctly on theocclusal surface. | 80-100% ProprietaryAliphatic UrethaneMethacrylate1-10% AmorphousPrecipitated Silica |
| Submission | Reliance OrthodonticsK210349 | Dentscare LtdaK192682 | Dentsply InternationalK882482 |
| 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 roomtemperature | 36 months at 5° to 27°C | 24 months at < 75 °F |
| Method ofCure | Light cure for 20 secondsfrom close range with a dentalcuring light of 1000 mW ormore. | Light cure. Data on time to cure notavailable at time of submission. | Light cure at variabletimes from 30 sec to 3minutes per use case. |
| Color | Pink | BlueColorless (UV Trace) | Clear, colorlessClear, blueClear, pinkClear, red |
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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(HighPerformance /Critical Area) | Test Result |
|---|---|---|---|---|
| Shear Bond StrengthEnamel | RD-022 | MPa | 5 sample average ≥ 8 | Pass16.47 ± 4.24 |
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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 StrengthSteel | RD-022 | MPa | 5 sample average ≥ 8 | Pass36.157 ± 1.37 |
|---|---|---|---|---|
| Shear Bond StrengthPorcelain | RD-022 | MPa | 5 sample average ≥ 8 | Pass21.54 ± 5.12 |
| Shear Bond StrengthAcrylic | RD-022 | MPa | 5 sample average ≥ 8 | Pass24.28 ± 3.57 |
| Flexural StrengthISO-4049:2019 | ISO-4049:2019 | MPa | 4 of 5 samples ≥ 80 | Pass5 of 5 samples > 80 |
| Hardness after Cure | QC-006 | N/mm2 | > 69 Top> 67 BottomAfter 20 s L/C | Pass>69 Top> 67 Bottom |
| Depth of Cure | ISO 4049:2019 | mm | 3 of 3 samples ≥ 1.5 | Pass3 of 3 samples > 1.5 |
| Sensitivity to AmbientLight | ISO 4049:2019 | Homogenous visualinspection | 3 of 3 samples | Pass3 of 3 sampleshomogenous |
| Water Sorption | ISO 4049:2019 | ug/mm3 | 4 of 5 < 40 | Pass5 of 5 < 40 |
| Water Solubility | ISO 4049:2019 | ug/mm3 | 4 of 5 < 7.5 | Pass5 of 5 < 7.5 |
| Biocompatibility | ISO 10993-5ISO 7405:2018 | N/A | Passes Cytotoxicityor Oral Toxicitytesting | Pass14 day oral toxicity |
| Storage and Shelf Life | Stability study for3.7 months at 50 °C | N/A | SBS. FlexuralStrength, andHardness after curepass after cure | Pass24 month shelf life at roomtemperature. |
| Packaging | RD-037 | N/A | Passes suitabilitytesting | 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.
§ 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.