(68 days)
Not Found
No
The device description and performance studies focus on chemical and physical properties, with no mention of AI/ML terms or functionalities.
Yes
Explanation: The device is used for debridement, removing the smear layer, and cleansing the root canal system, which are therapeutic actions to treat the root canal.
No
Triton is described as a "root canal cleanser" used for debridement, removing the smear layer, and cleansing the root canal system. Its function is to actively clean and remove debris, not to detect, monitor, or diagnose a condition.
No
The device description clearly states that Triton is a two-part aqueous solution, indicating it is a chemical substance, not software.
Based on the provided information, Triton is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "debridement, removing the smear layer, and cleansing the root canal system." This describes a treatment or procedural aid used within the patient's body (specifically, the root canal system of a tooth).
- Device Description: The description details a chemical solution used for cleaning and removing debris from the root canal. This is a direct application to the anatomical site.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample in vitro (outside the body), or provide information about a patient's health status based on a sample.
- Anatomical Site: The anatomical site is the "Oral cavity / Isolated tooth," which is a part of the living patient.
- Performance Studies: The performance studies listed (Shelf-Life, Working Time, Material Compatibility, Packaging Function) are focused on the physical and chemical properties of the solution and its packaging, not on diagnostic accuracy or performance in analyzing biological samples.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Triton's function is to physically clean and prepare a part of the body during a dental procedure, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity / Isolated tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed Dental Professionals
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)
The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of Triton:
- Shelf-Life Testing
- Working Time
- Material Compatibility
- Packaging Function (Equal Draw Testing)
Clinical performance is not deemed necessary.
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
August 18, 2021
Inter-Med / Vista Dental Brett Arand Senior Product Development Engineer 2200 South Street Racine, Wisconsin 53404
Re: K211813 Trade/Device Name: Triton Regulatory Class: Unclassified Product Code: KJJ Dated: July 15, 2021 Received: July 20, 2021
Dear Brett Arand:
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/cfpmp/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 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
1
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 medical devices and radiation-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,
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
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Indications for Use
510(k) Number (if known) K211813
Device Name
Triton
Indications for Use (Describe)
Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
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 5-510K SUMMARY-K211813
Applicant
Inter-Med / Vista Dental Products 2200 South Street Racine, WI, USA 53404 Contact Person: Brett Arand
Telephone Number: (262) 633-0755 Fax Number: (262) 636-9760 Email: barand(@vista-dental.com
| Date Prepared: | June 9th, 2021 |
|---|---|
| Prepared By: | Brett Arand |
Device Name
Proprietary Name: Triton Common Name: Cleanser, Root Canal Product Code: KJJ Device Class: Unclassified
Predicate Device
V-Mix (K193357) by Inter-Med / Vista Dental Products
- o Common Name: Cleanser, Root Canal
- 0 Product Code: KJJ
- o Device Class: Unclassified
Device Modification Summary
Triton, subject of the present special 510(k) notification, is a two-part, dual-action root canal cleanser. Previously, the product under the trade name V-Mix was approved under 510(k) number K193357. Triton consists of the same irrigating solution with no changes to formulation however it is packaged in a 2-part bottle instead of 2-part syringes. No changes were made to specific technical characteristics of the product. Labeling only changed as it corresponds to the change in packaging, i.e. a bottle and cap instead of syringe and tip. As Triton is equivalent to Vista's own predicate device V-Mix currently marketed in the U.S., a special 510(k) is the most appropriate premarket notification. The change from the name "V-Mix" to "Triton" is purely a branding change.
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Device Description
Triton is a two-part, dual-action root canal cleanser. Triton Part A is an aqueous solution that contains carboxylic acid chelating agents and surfactants. Triton Part B is an aqueous solution that contains sodium hypochlorite. Once the two solutions are mixed solution cleanses and debrides the root canal system by removing the organic debris during and after endodontic instrumentation.
This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.
Indications for Use
Triton is used for debridement, removing the smear layer, and cleansing the root canal system.
Technological Characteristics
All of the components found in Triton have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of components in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Triton for the indicated uses.
Device Comparison
Please reference Table 5-1 below for a comparison of Triton to the previously submitted V-Mix Device.
| Table 5-1: Comparison of the existing cleared 510(k) (V-Mix, K193357) to this special 510(k) | ||
|---|---|---|
| SUbmission. | ||
| Predicate Device | Subject Device | |
| Trade Name | V-Mix | Triton |
| 510(k) Number | K193357 | K211813 |
| Common Name | Cleanser, Root Canal | Cleanser, Root Canal |
| Device | ||
| Classification | Unclassified | Unclassified |
| Product code | KJJ | KJJ |
| Indications for | ||
| Use | V-Mix is used for debridement, | |
| removing the smear layer, and | ||
| cleansing the root canal system. | Triton is used for debridement, | |
| removing the smear layer, and | ||
| cleansing the root canal system. | ||
| Target Users | Licensed Dental Professionals | Licensed Dental Professionals |
| Anatomical Site | Oral cavity / Isolated tooth | Oral cavity / Isolated tooth |
| Part A | ||
| Description | Aqueous solution that contains | |
| carboxylic acid chelating agents | ||
| and surfactants | Aqueous solution that contains | |
| carboxylic acid chelating agents | ||
| and surfactants |
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| Part B | Aqueous solution that contains | Aqueous solution that contains |
|---|---|---|
| Description | sodium hypochlorite | sodium hypochlorite |
| Packaging | 10mL pre-filled dual cartridge | |
| syringe with applicator tip. Part A | ||
| and Part B are mixed in the tip as it | ||
| is dispensed. | Dual 8oz bottles with a dispensing | |
| cap. Standard syringes attach to a | ||
| luer activated valve on the | ||
| dispensing cap. Fluid is drawn into | ||
| the syringe from Bottle A and | ||
| Bottle B simultaneously and | ||
| equally. | ||
| Shelf Life | 9 Months | 30 Months |
| Biocompatibility | ||
| Testing/Analysis | ||
| Performed* | ISO 7405:2018 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ||
| ISO 10993-11:2017 | ISO 7405:2018 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ||
| ISO 10993-11:2017 | ||
| Risk | Acceptable, risk management has | |
| mitigated all identified risks to | ||
| acceptable levels; benefits of the | ||
| device outweigh any residual risks | Acceptable, risk management has | |
| mitigated all identified risks to | ||
| acceptable levels; benefits of the | ||
| device outweigh any residual risks | ||
| Prescription/OTC | Prescription | Prescription |
*Note: As the formula is not changing, reference is made to the cleared 510(k) K193357 Section
15 - Biocompatibility which contains all the ISO 10993 biocompatibility test reports.
Similarities between the subject device (Triton) and the already cleared device (V-Mix, K193357)
- The formula is identical between Triton and the already cleared device, V-Mix. ●
- Triton has identical indications for use as the already cleared device, V-Mix.
- Triton is classified under product code KJJ and shares the identical common name "Cleanser, Root Canal" as the already cleared device, V-Mix.
- Identical to the already cleared device. Triton is a non-sterile device. V-Mix. ●
- . Identical to the already cleared device, syringes and endodontic irrigating tips are used to deliver the device to the root canal space.
Triton is identical to the already cleared device, V-Mix, in every aspect besides the differences discussed below.
Differences between the subject device (Triton) and the already cleared device (V-Mix, K 193357)
- Triton is packaged in a 2-part bottle, whereas the already cleared device, V-Mix, was packaged in a 2-part syringe.
- This difference does not raise any concerns as test reports within the product's o design history file (DHF) support and confirm the packaging compatibility.
- Furthermore, the 2-part bottle of Triton is nearly analogous to the 2-part syringe o packaging of V-Mix but just in "bulk packaging" for economical efficiencies to the user.
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- Lastly, the 2-part bottle of Triton is only a packaging configuration for bulk storage o and sale of the product, as a syringe and endodontic irrigating tip is still required for clinical use in the root canal space which is commensurate with all existing endodontic irrigants already on the market. Therefore, the packaging change does not introduce any changes to clinical utility or use of the Triton device.
- As such, Inter-Med confirms Triton remains substantially equivalent to the cleared o device.
- Triton has a 30 month shelf-life. whereas the already cleared device. V-Mix. has a 9 month ● shelf-life.
- This difference does not raise any concerns as test reports within the product's O design history file (DHF) support and confirm the designated shelf-life durations.
- As such, Inter-Med confirms Triton remains substantially equivalent to the cleared o device.
Applicable Standards
- . ISO 7405:2018 - Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro . Cytotoxicity
- . ISO 10993-10:2010 - Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2017 - Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity
- ISO 14971:2019 Application of Risk Management to Medical Devices ●
Non-Clinical Performance Testing and Compliance
The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of Triton:
- Shelf-Life Testing ●
- Working Time
- Material Compatibility
- Packaging Function (Equal Draw Testing) .
Clinical Performance Testing and Compliance
Clinical performance is not deemed necessary.
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Conclusion
Triton is to be marketed by Inter-Med / Vista Dental Products, 2200 South St. Ste. A., Racine, WI 53404, and is substantially equivalent to V-Mix (K193357).