(291 days)
No
The device description and performance studies focus on the chemical and physical properties of the adhesives and etchant, with no mention of AI or ML.
No.
The device is an adhesive system used for bonding orthodontic brackets and appliances to teeth, which is a supportive function for orthodontic treatment, not a direct therapeutic action itself.
No
The device is an adhesive system used for bonding orthodontic appliances to teeth. It does not perform any diagnostic function.
No
The device description clearly states that the device consists of physical components such as adhesive paste, sealant, and etchant gel, which are applied to the tooth surface. It also mentions being polymerized by a dental curing light, indicating a physical interaction and material properties are central to its function.
Based on the provided information, the TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, and TP Orthodontics Etchant are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of these devices is to bond orthodontic appliances directly to the tooth surface. The etchant is used on the tooth structure itself. None of these processes involve analyzing a specimen taken from the body.
- The device description and intended use clearly describe a direct application to the tooth for a mechanical purpose (bonding). This is a therapeutic or restorative application, not a diagnostic one.
- There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, these devices fall under the category of dental devices used for orthodontic treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.
TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Product codes (comma separated list FDA assigned to the subject device)
DYH, KLE
Device Description
TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are:
- TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant.
- TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad.
The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth.
TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth's surface, enamel, dentin
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)
Clinical Performance Testing: No clinical performance testing was conducted on TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, and TP Orthodontics Etchant.
Non-Clinical Performance Testing: TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant bench testing was performed. The proposed device passed testing and performed similar to its predicate devices (test reports are attached to this submission).
Biocompatibility Testing: Biocompatibility testing TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive was performed per guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as discussed in the Biocompatibility section of this application. TP Orthodontics Etchant and the predicate device (American Orthodontics' Acid Etchant) have similar chemical composition, properties and utilize phosphoric acid CAS# 7664-38-2. The biocompatibility of these devices is equivalent; therefore, biocompatibility testing of TP Orthodontics Etchant was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
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October 14, 2022
TP Orthodontics, Inc. Cristiane Muller Clinical & Regulatory Affairs Manager 100 Center Plaza La Porte, Indiana 46350-9672
Re: K214054
Trade/Device Name: TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin And Tooth Conditioner Regulatory Class: Class II Product Code: DYH, KLE Dated: September 7, 2022 Received: September 16, 2022
Dear Cristiane Muller:
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
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) 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 (QS) 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214054
Device Name
TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant
Indications for Use (Describe)
TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.
TP Orthodontics Pre-Applied Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
TP Orthodontics Echant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
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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Image /page/3/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with an arrow wrapping around it on the left side. To the right of the globe is the text "TP Orthodontics, Inc."
September 7, 2022
510(k) Summary - K214054
Submitter Information
TP Orthodontics, Inc. 100 Center Plaza, La Porte, IN 46350-9672 Contact Person: Cristiane Muller Phone Number: 219.785.2591 Fax: 219.324.3029 E-mail: regulatory@tportho.com
Device Information
Trade Name: TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant Common Name: Adhesive, Bracket and Tooth Conditioner, Resin Product Code: DYH Classification Name: Bracket Adhesive Resin and Tooth Conditioner Regulation Number: 872-3750 Device Class: II Classification Panel: Dental
Primary Predicate Device
| Device | Applicant | 510(k) Number |
|---|---|---|
| BracePaste Adhesive | American Orthodontics | K160782 |
Secondary Predicate Devices
| Device | Applicant | 510(k) Number |
|---|---|---|
| APC Plus Adhesive | 3M Unitek Corp. | K020394 |
| Acid Etchant | American Orthodontics | K172953 |
Reference Predicate Devices
| Device | Applicant | 510(k) Number |
|---|---|---|
| Transbond XT Light Cured Orthodontic Adhesive/ | ||
| Transbond XT Primer | Unitek Corp. | K880393 |
| APC Flash-Free Adhesive | Unitek Corp. | K113197 |
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Image /page/4/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with an arrow wrapping around it on the left. To the right of the globe is the text "TP Orthodontics, Inc." in a simple, sans-serif font. The logo is clean and professional, suggesting a global reach for the company.
Indications for Use
TP Orthodontics Light Cure Adhesive System is indicated for use as an orthodontic bonding agent for metal brackets, ceramic brackets, and buccal tubes to the tooth's surface.
TP Orthodontics Pre-Applied Adhesive is indicated use in orthodontic appliance application and bonding for orthodontic treatment.
TP Orthodontics Acid Etchant is indicated for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Device Description and Summary of Technological Characteristics
TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive are light cure orthodontic adhesive used for bonding the orthodontic brackets, molar tubes, and buccal tubes to the surface of teeth for orthodontic treatment. The variations available are:
- . TP Orthodontics Light Cure Adhesive System, which consists of an adhesive paste (will be available in a pre-loaded syringe), and sealant.
- . TP Orthodontics Pre-Applied Adhesive, consisting of bracket adhesive pre-applied to the bracket pad.
The adhesives prevent bracket drift during placement, and is easy to clean-up excess (flash') prior to curing. The adhesive is polymerized ('cured') by exposure to a dental curing light, and once cured it creates a bond, attaching the orthodontic appliance to the teeth.
TP Orthodontics Etchant is a phosphoric acid etchant used on tooth enamel or dentin in preparation for orthodontic bonding. It is a blue gel and will be contained in a syringe, which will use disposable dispensing tips for its controlled application.
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Table 5.1. Substantial Equivalence Comparison
| Characteristic | TP Orthodontics
Light Cure Adhesive
System | BracePaste | Transbond XT (Light Cured
Orthodontic Adhesive/
Primer) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Proposed Device | Predicate Device | Reference Predicate |
| 510(k) | To be determined | K160782 | K880393 |
| Manufacturer | TP Orthodontics, Inc. | American Orthodontics | Unitek Corp. |
| Regulation Number | 21 CFR 872.3750 | 21 CFR 872.3750 | 21 CFR 872.3750 |
| Device Classification Name | Bracket Adhesive Resin and
Tooth Conditioner | Bracket Adhesive Resin and
Tooth Conditioner | Bracket Adhesive Resin and
Tooth Conditioner |
| Product Code | DYH | DYH | DYH |
| Device Class | Class II | Class II | Class II |
| Indications for Use | Indicated for use as an
orthodontic bonding agent for
metal brackets, ceramic
brackets, and buccal tubes to
the tooth's surface. | Intended for use as an
orthodontic bonding agent for
Metal Brackets, Ceramic
Brackets and Buccal Tubes
to the tooth's surface. | Designed for direct bonding
of ceramic orthodontic
brackets and metal brackets. |
| Dentition to be Used | Mixed and Permanent | Mixed and Permanent | Mixed and Permanent |
| Parts that can be Bonded | Fixed orthodontic appliance
(Brackets, Tubes,
Accessories). | Fixed orthodontic appliance
(Brackets, Tubes,
Accessories). | Fixed orthodontic appliance
(Brackets, Tubes,
Accessories). |
| Mode of Use | Light Cure orthodontic
adhesive intended for use in
bonding appliances for
orthodontic treatment.
Adhesive is applied to
appliance. Once part is
positioned, visible light is
used for curing the adhesive
and by this affix part to tooth. | Light Cure orthodontic
adhesive intended for use in
bonding appliances for
orthodontic treatment.
Adhesive is applied to
appliance. Once part is
positioned, visible light is
used for curing the adhesive
and by this affix part to tooth. | Light Cure orthodontic
adhesive intended for use in
bonding appliances for
orthodontic treatment.
Adhesive is applied to
appliance. Once part is
positioned, visible light is
used for curing the adhesive
and by this affix part to tooth. |
| Components | Paste and Sealant (primer) | Paste | Paste and Sealant (primer) |
| Delivery System | Syringe (paste) and bottle
with dropper (sealant) | Syringe/ Carpule | Syringe/ Carpule (paste) and
bottle with dropper (sealant) |
| Curing Mechanism | Orthodontic Curing Light | Orthodontic Curing Light | Orthodontic Curing Light |
| Curing Recommendations | IFU recommends following
curing light manufacturer's
directions.
Instructions are provided if
using a 300mW/cm2 and
average wavelength of 400-
500nm curing light | IFU recommends following
curing light manufacturer's
directions.
Instructions are provided if
using Blu Ray 3 (3000
mW/cm2), which is distributed
by American Orthodontics | IFU recommends following
curing light manufacturer's
directions.
Instructions are provided if
using 3M's Ortholux
Luminous Curing Light (1600
mW/cm2) |
| Resin Base | Methacrylate Monomers | Methacrylate Monomers | Methacrylate Monomers |
| Filler Composition (paste) | Silane treated silica and
silane treated glass | Silane treated silica and
silane treated glass
(aluminum boron silicate
glass) | Silica and Quartz |
| Catalyst | Camphoroquinone | Camphoroquinone | Camphoroquinone |
| Prescription (Rx) or Over-the-
Counter (OTC) | Rx | Rx | Rx |
| Characteristic | TP Orthodontics
Pre-Applied Adhesive | APC Plus Adhesive | |
| Device | Proposed Device | Predicate Device | |
| 510(k) | To be determined | K020394 | |
| Manufacturer | TP Orthodontics, Inc. | 3M Unitek Corp. | |
| Regulation Number | 21 CFR 872.3750 | 21 CFR 872.3750 | |
| Device Classification
Name | Bracket Adhesive Resin and Tooth Conditioner | Bracket Adhesive Resin and Tooth Conditioner | |
| Product Code | DYH | DYH, EJF, DYW | |
| Device Class | Class II | Class II | |
| Indications for Use | Indicated for use in orthodontic appliance
application and bonding for orthodontic
treatment. | Indicated for use in orthodontic appliance
application and bonding for orthodontic
treatment. | |
| Dentition to be Used | Mixed and Permanent | Mixed and Permanent | |
| Bracket Types | TP Orthodontics commercially available metal
and ceramic brackets. | Unitek commercially available metal and
ceramic brackets. | |
| Mode of Use | Light Cure orthodontic adhesive intended for
use in bonding appliances for orthodontic
treatment. Adhesive is already pre-applied to
appliance. Once part is positioned, visible light
is used for curing the adhesive and by this affix
part to tooth. | Light Cure orthodontic adhesive intended for
use in bonding appliances for orthodontic
treatment. Adhesive is already pre-applied to
appliance. Once part is positioned, visible light
is used for curing the adhesive and by this affix
part to tooth | |
| Delivery System | Pre-applied | Pre-applied | |
| Curing Mechanism | Orthodontic Curing Light | Orthodontic Curing Light | |
| Curing Recommendations | IFU recommends following curing light
manufacturer's directions.
Instructions are provided if using a 300mW/cm2
and average wavelength of 400-500nm curing
light | IFU recommends following curing light
manufacturer's directions.
Instructions are provided if using 3M's Ortholux
Luminous Curing Light (1600 mW/cm2) | |
| Resin Base | Methacrylate Monomers | Methacrylate Monomers | |
| Filler Composition | Silica and Glass | Silica, Glass and Quartz. | |
| Catalyst | Camphoroquinone | Camphoroquinone | |
| Prescription (Rx) or Over-
the-Counter (OTC) | Rx | Rx | |
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Table 5.2. TP Orthodontics Adhesive Comparison – TPO® Pre-Applied Adhesive
7
| Characteristic | TP Orthodontics Etchant | Acid Etchant |
|---|---|---|
| Device | Proposed Device | Predicate Device |
| 510(k) | To be determined | K172953 |
| Manufacturer | TP Orthodontics, Inc. | American Orthodontics |
| Regulation Number | 21 CFR 872.3750 | 21 CFR 872.3200 |
| Device Classification | ||
| Name | Bracket Adhesive Resin and Tooth Conditioner | Agent, tooth bonding, resin |
| Product Code | DYH, KLE | KLE |
| Device Class | Class II | Class II |
| Indications for Use | TP Orthodontics Etchant is indicated for etching | |
| enamel and dentin to promote adhesion of | ||
| primer/bonding agent adhesives to tooth | ||
| structure and restorative materials. | Acid Etchant is a phosphoric acid etchant | |
| used for etching enamel and dentin to | ||
| promote adhesion of primer/bonding | ||
| agent adhesives to tooth structure and | ||
| restorative materials. | ||
| Dentition to be Used | Mixed and Permanent | Mixed and Permanent |
| Mode of Use | Applied to tooth surface to prepare it for | |
| orthodontic bonding. | Applied to tooth surface to prepare it for | |
| orthodontic bonding. | ||
| Delivery System | Syringe | Syringe |
| % Phosphoric Acid | 37% (CAS 7664-38-2) | 37% (CAS 7664-38-2) |
| Material Composition | Water, phosphoric acid, silica, dye | Water, phosphoric acid, silica, dye |
| Consistency | Thixotropic Gel/Thickened Fluid | Thixotropic Gel/Thickened Fluid |
| Prescription (Rx) or | ||
| Over-the-Counter (OTC) | Rx | Rx |
Table 5.3. TP Orthodontics Adhesive Comparison - TPO Enamel Etchant
Clinical Performance Testing
No clinical performance testing was conducted on TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, and TP Orthodontics Etchant.
Non-Clinical Performance Testing
TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant bench testing was performed. The proposed device passed testing and performed similar to its predicate devices (test reports are attached to this submission).
Biocompatibility Testing
Biocompatibility testing TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive was performed per guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as discussed in the Biocompatibility section of this application.
TP Orthodontics Etchant and the predicate device (American Orthodontics' Acid Etchant) have similar chemical composition, properties and utilize phosphoric acid CAS# 7664-38-2. The biocompatibility of these devices is equivalent; therefore, biocompatibility testing of
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Image /page/8/Picture/0 description: The image shows the logo for TP Orthodontics, Inc. The logo consists of a stylized globe with an arrow wrapping around it. The text "TP Orthodontics, Inc." is placed to the right of the globe image. The text is in a simple, sans-serif font.
TP Orthodontics Etchant was not performed.
Substantial Equivalence Conclusion
TP Orthodontics Light Cure Adhesive System and TP Orthodontics Pre-Applied Adhesive present substantially equivalent indication for use, technological characteristics, mechanism of action, composition, and biocompatibility as its predicate devices. There are slight differences in the lanquage of the instructions for use, however these differences do not impact safety and efficacy of the device. TP Orthodontics Light Cure Adhesive System has similar components as its reference predicate device, being comprised of an adhesive paste and liquid sealant/ primer.
TP Orthodontics Etchant presents substantially equivalent indication for use, technological characteristics, mechanism of action, composition, and biocompatibility as its predicate devices. It is concluded that TP Orthodontics Light Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive and TP Orthodontics Etchant are substantially equivalent to their predicate devices.