TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

Q: Who is the manufacturer of TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

Tp Orthodontics, Inc. filed the 510(k) submission for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 (K214054).

Q: What is the FDA product code for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

DYH. It is classified under 21 CFR 872.3750 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

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

Q: What are the predicate devices for TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

BracePaste Adhesive (K160782); APC Plus Adhesive (K020394); Acid Etchant (K172953).

Q: Who can help prepare an FDA 510(k) submission like TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520?

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.

K214054 · Tp Orthodontics, Inc. · DYH · Oct 14, 2022 · Dental

Device Facts

Record ID	K214054
Device Name	TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
Applicant	Tp Orthodontics, Inc.
Product Code	DYH · Dental
Decision Date	Oct 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3750
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

System comprises light-cure orthodontic adhesive (paste/sealant) and phosphoric acid etchant; used for bonding orthodontic appliances (brackets, buccal tubes) to teeth. Adhesive applied to appliance or tooth; cured via dental curing light; prevents bracket drift during placement; allows excess flash cleanup. Etchant (37% phosphoric acid gel) applied to enamel/dentin to prepare surface for bonding. Used in clinical orthodontic settings by dental professionals. Output is mechanical bond between appliance and tooth. Benefits include secure appliance attachment and efficient orthodontic treatment.

Clinical Evidence

No clinical performance testing was conducted. Substantial equivalence is supported by bench testing and comparison of chemical/technological characteristics to legally marketed predicate devices.

Technological Characteristics

Light-cure orthodontic adhesive system (methacrylate monomers, silane-treated silica/glass fillers, camphoroquinone catalyst). Etchant is 37% phosphoric acid gel (CAS 7664-38-2). Curing via dental curing light (400-500nm). Delivery via syringe or pre-applied to bracket pads. Biocompatibility evaluated per ISO 10993-1.

Indications for Use

Indicated for orthodontic bonding of metal/ceramic brackets and buccal tubes to tooth surfaces in mixed and permanent dentition. Etchant indicated for enamel/dentin etching to promote adhesion.

Regulatory Classification

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.

Predicate Devices

BracePaste Adhesive (K160782)
APC Plus Adhesive (K020394)
Acid Etchant (K172953)

Reference Devices

Transbond XT Light Cured Orthodontic Adhesive/Transbond XT Primer (K880393)
APC Flash-Free Adhesive (K113197)

Related Devices

K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive · Ormco Corporation · Jan 3, 2025
K072978 — TENDER ORTHO BOND-ENA BOND-ENA ETCH · Micerium S.P.A. · Jan 17, 2008
K030980 — DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE · Dentaurum · Aug 25, 2003
K113401 — ORTHO-1(NOT FINALIZED) · Bisco, Inc. · Feb 7, 2012
K142880 — DMRC Light Cure Orthodontic Adhesive System · Daville Materials, LLC · Feb 4, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. 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) #### 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." {3}------------------------------------------------ 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 | {4}------------------------------------------------ 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. {5}------------------------------------------------ #### 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 | | {6}------------------------------------------------ ## 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 {8}------------------------------------------------ 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.