(162 days)
No
The summary describes a composite gel and its physical properties, with no mention of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is used for creating occlusal buildups and repairing retainers, which are structural and corrective applications rather than therapeutic.
No
The device is a composite gel used for creating occlusal buildups (bite turbos) and for repairing retainers, which are therapeutic and restorative applications, not diagnostic.
No
The device description clearly states it is a "flowable light cure composite gel" dispensed from a syringe, indicating it is a physical material and not software. The performance studies also focus on physical properties like bond strength, hardness, and solubility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating occlusal buildups (bite turbos) and as a retainer repair composite. These are procedures performed directly on a patient's teeth and dental appliances.
- Device Description: The description details a composite gel used for bonding to various dental materials in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) or on dental appliances that are used in the body.
N/A
Intended Use / Indications for Use
TKO is a pink, flowable light cure composite gel for the creation of occlusal buildups (bite turbos) and as a retainer repar composite.
Product codes (comma separated list FDA assigned to the subject device)
EBF
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.
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
Orthodontic or Dental Office
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 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:
- Shear Bond Strength Enamel: Test RD-022, Unit MPa, Requirement 5 sample average ≥ 8, Test Result Pass 16.47 ± 4.24
- Shear Bond Strength Steel: Test RD-022, Unit MPa, Requirement 5 sample average ≥ 8, Test Result Pass 36.157 ± 1.37
- Shear Bond Strength Porcelain: Test RD-022, Unit MPa, Requirement 5 sample average ≥ 8, Test Result Pass 21.54 ± 5.12
- Shear Bond Strength Acrylic: Test RD-022, Unit MPa, Requirement 5 sample average ≥ 8, Test Result Pass 24.28 ± 3.57
- Flexural Strength ISO-4049:2019: Test ISO-4049:2019, Unit MPa, Requirement 4 of 5 samples ≥ 80, Test Result Pass 5 of 5 samples > 80
- Hardness after Cure: Test QC-006, Unit N/mm2, Requirement > 69 Top, > 67 Bottom After 20 s L/C, Test Result Pass >69 Top, > 67 Bottom
- Depth of Cure: Test ISO 4049:2019, Unit mm, Requirement 3 of 3 samples ≥ 1.5, Test Result Pass 3 of 3 samples > 1.5
- Sensitivity to Ambient Light: Test ISO 4049:2019, Unit Homogenous visual inspection, Requirement 3 of 3 samples, Test Result Pass 3 of 3 samples homogenous
- Water Sorption: Test ISO 4049:2019, Unit ug/mm3, Requirement 4 of 5
§ 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.
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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
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
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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 Orthodontics | ||
| K210349 | Dentscare Ltda | ||
| K192682 | Dentsply International | ||
| K882482 | |||
| Model | TKO Composite Bite Turbo | ||
| Gel | 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 light | ||
| cure composite gel for the | |||
| creation of occlusal buildups | |||
| (bite turbos) and as a retainer | |||
| repair composite. | The product is indicated for | ||
| cementing orthodontic bands and is | |||
| also suitable for temporary dental | |||
| disocclusion during orthodontic | |||
| treatment. | Triad Gel Material is a | ||
| visible light cure material | |||
| indicated for the | |||
| fabrication of functional | |||
| orthodontic appliances, | |||
| repairs, relines and | |||
| rebases. | |||
| 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. It is categorized as | |||
| a permanent externally | |||
| communicating device that | |||
| contacts tissue/bone/dentin. | Ortho Bite is a light-curing self- | ||
| adhesive composite with self- | |||
| levelling characteristics and surface | |||
| hardness. The product is colored in | |||
| order to facilitate its identification | |||
| during application and removal. | Triad Gel Material is | ||
| suitable where materials | |||
| with high flow | |||
| characteristics are | |||
| desired, such as when | |||
| encapsulating and | |||
| retaining orthodontic | |||
| wires, mesh, etc. Triad | |||
| Gel Material contains no | |||
| methyl methacrylate | |||
| monomer. | |||
| Chemical | |||
| Composition | Urethane Dimethacrylate | ||
| Triethylene Glycol | |||
| Dimethacrylate | |||
| Hexafunctional Urethane | |||
| Acrylate Oligomer | |||
| 2-Ethyl-4- | |||
| dimethylaminobenzoate | |||
| Camphorquinone | |||
| FD&C Red #40 | The adhesives contain methacrylate | ||
| as resin fillers and silica that is used | |||
| as fillers. Its composition includes | |||
| dimethacrylate monomers, HEMA | |||
| Phosphate, traditional | |||
| Camphorquinone/DABE system as | |||
| photoinitiator and silica as load | |||
| particle. The combination of silica | |||
| load fillers with the dimethacrylate | |||
| monomer composition results in a | |||
| viscosity that allows it to be handled | |||
| and applied without running off the | |||
| application area. The presence of | |||
| HEMA Phosphate allows adhesion | |||
| to the enamel surface, which is a | |||
| known feature of composite cements | |||
| indicated for bracket bonding. The | |||
| thixotropy allows the product to have | |||
| self-levelling capability, known as a | |||
| shear thinning property that makes | |||
| the composite settle correctly on the | |||
| occlusal surface. | 80-100% Proprietary | ||
| Aliphatic Urethane | |||
| Methacrylate | |||
| 1-10% Amorphous | |||
| Precipitated Silica | |||
| Submission | Reliance Orthodontics | ||
| K210349 | Dentscare Ltda | ||
| K192682 | Dentsply International | ||
| 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 | ||
| temperature | 36 months at 5° to 27°C | 24 months at 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 | Homogeno
us visual
inspection | 3 of 3 samples | Pass
3 of 3 samples
homogenous |
| Water Sorption | ISO 4049:2019 | ug/mm3 | 4 of 5