(106 days)
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.
The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files. Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.
Analysis of provided document for Acceptance Criteria and Device Performance Study Details:
Based on the provided FDA 510(k) summary for "Sealer Solvent" (K241354), the document extensively details the device's characteristics, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states:
- "Clinical performance testing has not been performed for Sealer Solvent."
Therefore, the document does not contain information about a study that proves the device meets clinical acceptance criteria, nor does it provide details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set. The focus of the provided information is on non-clinical (laboratory) testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the available information in relation to your request, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics for the device (e.g., a specific percentage of material removal, or a target softening time). Instead, it describes various tests performed and implies the device met the requirements for these non-clinical tests to demonstrate substantial equivalence.
Implied Performance and Testing:
| Test Category | Description of Test / Implied Performance |
|---|---|
| Dissolution Testing | Performed to assess the device's ability to dissolve materials. (Specific results not provided, but passing implied for 510(k)). |
| In-Vitro Canal Performance Testing | Performed to evaluate performance within a simulated root canal. (Specific results not provided, but passing implied for 510(k)). |
| Shelf-Life Verification | Verified a shelf life of 36 months. |
| Biocompatibility Analysis | All patient-contacting components evaluated per ISO 7405 / ISO 10993-1. Meets requirements. |
| Cytotoxicity Testing | Performed per ISO 10993-5 (in vitro). Meets requirements. |
| Anti-microbial Testing | Performed. (Specific results not provided, but passing implied for 510(k)). |
| Transit Testing | Performed. (Specific results not provided, but passing implied for 510(k)). |
Comparison to Predicate Device (Technological Characteristics):
The document emphasizes that the Sealer Solvent's technological characteristics are "very similar" to the predicate device (Ultradent Citric Acid Irrigant 20%):
- Same function: Cleanses root canal.
- Active Ingredients: Both contain Citric Acid at 20%.
- Mechanism of Action: Both aim to dissolve inorganic materials.
- Form of Use: Both filled into syringes and delivered via dental irrigation tip.
- Non-sterile.
- External communicating device with limited (≤24 hour) contact time.
- Prescription device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based non-clinical tests rather than human clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set with human data requiring expert ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set with human data requiring adjudication was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (a solvent), not an AI-assisted diagnostic tool or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and controls for mechanical/chemical dissolution, biocompatibility, and antimicrobial efficacy testing. It would not involve expert consensus, pathology, or outcomes data in the human clinical sense.
8. The sample size for the training set:
- Not applicable. No AI/machine learning model was developed, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. No AI/machine learning model was developed, so there is no training set or associated ground truth establishment.
In summary, the provided document focuses solely on the non-clinical (laboratory) testing and comparison to a predicate device to establish substantial equivalence for a solvent, without any human clinical performance data or studies involving AI or expert readers.
{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 27, 2024
Inter-Med, Inc. Brett Arand Sr. Product Development Engineer 2200 South Street Racine, Wisconsin 53575
Re: K241354
Trade/Device Name: Sealer Solvent Regulatory Class: Unclassified Product Code: KJJ Dated: May 13, 2024 Received: July 31, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
{1}------------------------------------------------
Page
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Bobak Shirmohammadi -5
For Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
{2}------------------------------------------------
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K241354
Device Name Sealer Solvent
Indications for Use (Describe)
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and systems including the removal of foreign material and debris during root canal therapy.
| 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."
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a black line underneath. To the right of the word is a blue globe, and to the right of the globe is the word "INC." in black.
Image /page/4/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" are the words "Dental Products" in a smaller font. The logo is simple and clean, with a focus on the company name and the mountain range graphic.
510(k) Summary Sealer Solvent
Updated Per Hold Letter Received July 12, 2024
1. 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 |
July 29th, 2024 Date Prepared: Prepared By: Brett Arand
2. Device Name
| Proprietary Name: | Sealer Solvent |
|---|---|
| Classification Name: | Cleanser, root canal |
| CRF Number: | NA |
| Product Code: | KJJ |
| Device Class: | Unclassified |
3. Predicate Device
Sealer Solvent is substantially equivalent to the legally marketed device Citric Acid 20% Solution (K063703), submitted by Ultradent Products, Inc. and cleared on December 21st, 2006, product code KJJ.
Device Description 4.
The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files.
Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Intermed Inc. The word "intermed" is written in blue, with a blue globe to the right of the word. The letters "INC." are written in black to the right of the globe.
Image /page/5/Picture/1 description: The image is a logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".
cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.
This is the only 510(k) for the Sealer Solvent medical device, no prior 510(k)s have been submitted.
ડ. Intended Use
Sealer Solvent is a device that cleanses root canal systems by irrigating root canals.
6. Indication for Use
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.
7. Technological Characteristics and Substantial Equivalence
The technological characteristics of the Sealer Solvent are similar to the predicate device Ultradent Citric Acid Irrigant 20% (K063703). The Sealer Solvent and the predicate device Ultradent Citric Acid Irrigant 20% (K063703) perform the same function, which is to cleanse the root canal. A comprehensive comparison of technological characteristics and substantial equivalence between the devices is provided below.
Table 5-1: Predicate and Proposed Device Comparison Table
| Proposed DeviceSealer Solvent | Predicate Device20% Citric Acid Irrigant | Reference DeviceEDS Combo-Rinse | Reference DeviceEndocyn Root CanalIrrigation Solution | Proposed DeviceSealer Solvent | Predicate Device20% Citric Acid Irrigant | Reference DeviceEDS Combo-Rinse | Reference DeviceEndocyn Root CanalIrrigation Solution | ||
|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | Inter-Med, Inc / VistaApex | Ultradent, Inc. | Essential DentalSystems, Inc. | Oculus InnovativeSciences | Class | Unclassified | Unclassified | Unclassified | Unclassified |
| 510(k) | K241354Subject of this 510(k)submission | K063703 | K140846 | K141352 | FDAClassificationName andCFR Number | Cleanser, Root Canal | Cleanser, Root Canal | Cleanser, RootCanal | Cleanser, Root Canal |
| Trade name | Sealer Solvent | Citric Acid 20% | EDS Combo-Rinse | Endocyn Root CanalIrrigation Solution | Product code | KJJ | KJJ | KJJ | KJJ |
| Intended Use | Sealer Solvent is a devicethat cleanses root canalsystems by irrigating rootcanals. | Facilitates removal ofcalcium hydroxide fromcanal walls, and functionsas a mildetchant/conditioner forsmear layer removal. | EDS Combo-Rinseis a device thatcleanses root canalsystems byirrigating rootcanals. | Endocyn Root CanalIrrigation Solution isintended to irrigate,cleanse, and debride rootcanal systems includingthe removal of foreignmaterial and debrisduring root canaltherapy. It is alsointended to provide forlubrication and irrigationduring root canalinstrumentation. | |||||
| Indications forUse | Sealer Solvent, a rootcanal cleanser, isintended to irrigate,cleanse, and debride rootcanal systems includingthe removal of foreignmaterial and debrisduring root canaltherapy. | Citric Acid 20%, a rootcanal cleanser, is intendedto etch root canal walls justprior to obturation to allowan optimum seal. | EDS Combo-Rinseis intended tocleanse root canalsystems byirrigating rootcanals. | ||||||
| Target Users | Licensed DentalProfessionals | Licensed DentalProfessionals | Licensed DentalProfessionals | Licensed DentalProfessionals | |||||
| IntendedPopulation | Patients undergoingendodontic root canal | Patients undergoingendodontic root canalprocedures | Patients undergoingendodontic rootcanal procedures | Patients undergoingendodontic root canalprocedures |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath. To the right of the word is a blue globe with white lines.
Image /page/6/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below the word "VISTA" is the text "Dental Products" in a smaller font. The logo is simple and modern, and the use of the mountain range suggests a connection to nature or the outdoors.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a horizontal line underneath. To the right of the word is a blue globe with white grid lines, and the letters "INC" are written in black to the right of the globe.
Image /page/7/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below "VISTA" is the text "Dental Products" in a smaller font. The logo is primarily blue and black.
| Proposed DeviceSealer Solvent | Predicate Device20% Citric Acid Irrigant | Reference DeviceEDS Combo-Rinse | Reference DeviceEndocyn Root CanalIrrigation Solution | |
|---|---|---|---|---|
| procedures, includingretreatment procedures | ||||
| Anatomicalsite | Oral cavity / Isolatedtooth | Oral cavity / Isolated tooth | Oral cavity / Isolatedtooth | Oral cavity / Isolatedtooth |
| ActiveIngredients(bold text addedto highlightsimilarities incompositionbetween subjectdevice andpredicatedevices) | Citric Acid at 20% | Citric Acid at 20% | EDTA (a type ofchelator) | Sodium hypochlorite |
| InactiveIngredients | Proprietary chelators &surfactants, pH modifier,water | Polydimethyl siloxane,orange colorant, water | Unknowningredients, Water | Water |
| pH | 2-5 | 1.7 | Unknown | Unknown |
| Properties | Clear, water-likeconsistency | Orange-tinted, slightlythickened | Clear, colorless,water-likeconsistency | Clear, colorless, water-like consistency |
| Mechanism ofAction / | Sealer Solvent containscitric acid and otheringredients that havebeen specifically | Citric acid helps removecalcium hydroxide, andfunctions as a mildetchant/conditioner for | Chelator helpsremove smear layervia chelation | Helps debride andcleanse the root canal |
| Proposed DeviceSealer Solvent | Predicate Device20% Citric Acid Irrigant | Reference DeviceEDS Combo-Rinse | Reference DeviceEndocyn Root CanalIrrigation Solution | |
| Principle ofOperation | formulated to dissolveinorganic materials fromroot canal walls | smear layer removal viachelation | ||
| Applicationmethod | Filled into syringes anddelivered via choice ofdental irrigation tip | Filled into syringes anddelivered via choice ofdental irrigation tip | Filled into syringesand delivered viachoice of dentalirrigation tip | Filled into syringes anddelivered via choice ofdental irrigation tip |
| Packaging &Storage | • 4 oz (118mL) refillbottle, no specialstorage conditions. | • 30 mL refill syringe, nospecial storageconditions. | • Bottle | • Bottle |
| Nature of BodyContact (ISO7405:2018) | External communicatingdevice with limited (≤24hour) contact time | External communicatingdevice with limited (≤24hour) contact time | Externalcommunicatingdevice with limited(≤24 hour) contacttime | External communicatingdevice with limited (≤24hour) contact time |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Shelf-Life | Shelf life is 36 months | Shelf life is 30+ months | Unknown | Unknown |
| CytotoxicityTesting /AnalysisPerformed | All components thatmake patient contacthave been evaluatedaccording to ISO 7405 / | Meets Requirements | Meets Requirements | Meets Requirements |
| Proposed DeviceSealer Solvent | Predicate Device20% Citric Acid Irrigant | Reference DeviceEDS Combo-Rinse | Reference DeviceEndocyn Root CanalIrrigation Solution | |
| Prescription /OTC | Prescription | Prescription | Prescription | Prescription |
| Standards | ISO 7405:2018ISO 10993-1:2018ISO 10993-5:2009ISO 14971:2019ISO 15223-1:2021ISO 11014:2009ISO 20417:2021 | Unknown | Unknown | Unknown |
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath. To the right of the word is a blue globe with white lines.
Image /page/8/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below the word "VISTA" is the phrase "Dental Products" in a smaller font. The logo is simple and clean, and the use of the mountain range suggests a connection to nature or the outdoors.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a black line underneath. To the right of the word is a blue globe. The letters "INC." are written in black to the right of the globe.
Image /page/9/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in a sans-serif font. Below the word "VISTA" is the text "Dental Products" in a smaller font. The logo is primarily blue and white.
| Applicable Standards | |
|---|---|
| ISO 7405:2018 | Dentistry - Evaluation of biocompatibility of medical devices usedin dentistry |
| ISO 10993-1:2018 | Biological evaluation of medical devices |
| ISO 10993-5:2009 | Biological evaluation of medical devices Part 5 -Tests for in vitrocytotoxicity |
| ISO 14971:2019 | Application of Risk Management to Medical Devices |
| ISO 15223-1:2021 | Symbols to be used with information to be supplied by themanufacturer |
| ISO 11014:2009 | Safety data sheet for chemical products |
| ISO 20417:2021 | Medical devicesInformation to be supplied by the manufacturer |
Non-Clinical Performance Testing and Compliance 8.
The technological characteristics of Sealer Solvent are very similar to the predicate Citric Acid Irrigant 20% (K063703). Sealer Solvent and the predicate Citric Acid Irrigant 20% (K063703) are both root canal cleansers that perform similar functions. Sealer Solvent removes inorganic solids from the root canal walls, such as smear layer, bioceramic
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is written in blue, with a line underneath it. To the right of the word is a blue globe with white lines. The letters "INC." are written in black to the right of the globe.
Image /page/10/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features a stylized mountain range above the word "VISTA" in blue, with a trademark symbol next to it. Below the word "VISTA" is the phrase "Dental Products" in a smaller font size.
sealer, MTA, or calcium hydroxide, while Citric Acid Irrigant 20% (K063703) removes inorganic solids found in smear layer. The following performance tests were conducted as part of design verification:
- Dissolution testing ●
- In-Vitro Canal Performance Testing ●
- Shelf-Life Verification ●
- Biocompatibility Analysis
- Cytotoxicity testing ●
- Anti-microbial testing
- Transit Testing ●
Clinical Performance Data 9.
Clinical performance testing has not been performed for Sealer Solvent.
10. Conclusion as to Substantial Equivalence
The Sealer Solvent is to be marketed by Inter-Med, Inc., 2200 South Street, Racine, WI 53404, and is substantially equivalent to the predicate device. Ultradent Citric Acid 20%. The subject medical device has very similar indications for use, and similar technical characteristics, principles of operation and performance characteristics to the predicate device. The Sealer Solvent is safe and effective when used for the described indications. Any differences between the subject medical device and predicate medical device have been fully addressed and do not raise any additional safety or efficacy concerns. Therefore, it has been concluded that the Sealer Solvent is substantially equivalent to the predicate device, Ultradent Citric Acid 20%.
N/A