Who is the manufacturer of Sealer Solvent?

Inter-Med, Inc. filed the 510(k) submission for Sealer Solvent (K241354).

What is the FDA product code for Sealer Solvent?

KJJ. as a Class U device in the DE panel.

What is the regulatory pathway for Sealer Solvent?

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

Who can help prepare an FDA 510(k) submission like Sealer Solvent?

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.

Sealer Solvent

Q: What are the predicate devices for Sealer Solvent?

Citric Acid 20% Solution (K063703).

K241354 · Inter-Med, Inc. · KJJ · Aug 27, 2024 · DE

Device Facts

Record ID	K241354
Device Name	Sealer Solvent
Applicant	Inter-Med, Inc.
Product Code	KJJ · DE
Decision Date	Aug 27, 2024
Decision	SESE
Submission Type	Traditional
Device Class	Class U

Intended Use

Sealer Solvent is a device that cleanses root canal systems by irrigating root canals.

Device Story

Sealer Solvent is an aqueous-based root canal irrigant used during endodontic therapy and retreatment. It is delivered via syringe and needle tip by licensed dental professionals in a clinical setting. The device functions by softening and dissolving bioceramic sealers, smear layer, and calcium hydroxide from canal walls, facilitating their removal via flushing or mechanical instrumentation. By cleansing the canal of inorganic solids and debris, the device prepares the root canal system for obturation. It provides a clinical benefit by aiding in the effective removal of materials during retreatment and standard endodontic procedures.

Clinical Evidence

No clinical performance testing was performed. Evidence is based on bench testing, including dissolution testing, in-vitro canal performance testing, shelf-life verification, biocompatibility analysis, cytotoxicity testing, anti-microbial testing, and transit testing.

Technological Characteristics

Aqueous-based irrigant containing 20% citric acid, proprietary chelators, surfactants, and pH modifiers. pH range 2-5. Delivered via syringe and dental irrigation tip. Non-sterile. Complies with ISO 7405:2018, ISO 10993-1:2018, ISO 10993-5:2009, ISO 14971:2019, ISO 15223-1:2021, ISO 11014:2009, and ISO 20417:2021.

Indications for Use

Indicated for patients undergoing endodontic root canal therapy to irrigate, cleanse, and debride root canal systems, including the removal of foreign material and debris.

Predicate Devices

Citric Acid 20% Solution (K063703)

Reference Devices

EDS Combo-Rinse (K140846)
Endocyn Root Canal Irrigation Solution (K141352)

Related Devices

K980633 — ENDOSOLV E · Specialites Septodont · May 1, 1998
K061689 — AQUATINE EC ENDODONTIC CLEANSER · Puricore, Inc. · Aug 24, 2006
K032361 — ENDOPURE ROOT CANAL CLEANSER · Dentsply Intl. · Jan 12, 2004
K150020 — Irritrol, EDS Combo-Rinse · Essential Dental Systesm, Inc. · Feb 25, 2015
K141352 — ENDOCYN ROOT CANAL IRRIGATION SOLUTION · Oculus Innovative Sciences · Aug 18, 2014

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). 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) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 K241354 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 Device Sealer Solvent | Predicate Device 20% Citric Acid Irrigant | Reference Device EDS Combo-Rinse | Reference Device Endocyn Root Canal Irrigation Solution | | Proposed Device Sealer Solvent | Predicate Device 20% Citric Acid Irrigant | Reference Device EDS Combo-Rinse | Reference Device Endocyn Root Canal Irrigation Solution | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------|----------------------------------------------|-------------------------------------|---------------------------------------------------------------| | Manufacturer | Inter-Med, Inc / Vista Apex | Ultradent, Inc. | Essential Dental Systems, Inc. | Oculus Innovative Sciences | Class | Unclassified | Unclassified | Unclassified | Unclassified | | 510(k) | K241354 Subject of this 510(k) submission | K063703 | K140846 | K141352 | FDA Classification Name and CFR Number | Cleanser, Root Canal | Cleanser, Root Canal | Cleanser, Root Canal | Cleanser, Root Canal | | Trade name | Sealer Solvent | Citric Acid 20% | EDS Combo-Rinse | Endocyn Root Canal Irrigation Solution | Product code | KJJ | KJJ | KJJ | KJJ | | Intended Use | Sealer Solvent is a device that cleanses root canal systems by irrigating root canals. | Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal. | EDS Combo-Rinse is a device that cleanses root canal systems by irrigating root canals. | Endocyn Root Canal Irrigation Solution is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy. It is also intended to provide for lubrication and irrigation during root canal instrumentation. | | | | | | | Indications 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. | Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal. | EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals. | | | | | | | | Target Users | Licensed Dental Professionals | Licensed Dental Professionals | Licensed Dental Professionals | Licensed Dental Professionals | | | | | | | Intended Population | Patients undergoing endodontic root canal | Patients undergoing endodontic root canal procedures | Patients undergoing endodontic root canal procedures | Patients undergoing endodontic root canal procedures | | | | | | {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 Device Sealer Solvent | Predicate Device 20% Citric Acid Irrigant | Reference Device EDS Combo-Rinse | Reference Device Endocyn Root Canal Irrigation Solution | |-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------------------------| | | procedures, including retreatment procedures | | | | | Anatomical site | Oral cavity / Isolated tooth | Oral cavity / Isolated tooth | Oral cavity / Isolated tooth | Oral cavity / Isolated tooth | | Active Ingredients (bold text added to highlight similarities in composition between subject device and predicate devices) | Citric Acid at 20% | Citric Acid at 20% | EDTA (a type of chelator) | Sodium hypochlorite | | Inactive Ingredients | Proprietary chelators & surfactants, pH modifier, water | Polydimethyl siloxane, orange colorant, water | Unknown ingredients, Water | Water | | pH | 2-5 | 1.7 | Unknown | Unknown | | Properties | Clear, water-like consistency | Orange-tinted, slightly thickened | Clear, colorless, water-like consistency | Clear, colorless, water- like consistency | | Mechanism of Action / | Sealer Solvent contains citric acid and other ingredients that have been specifically | Citric acid helps remove calcium hydroxide, and functions as a mild etchant/conditioner for | Chelator helps remove smear layer via chelation | Helps debride and cleanse the root canal | | | Proposed Device Sealer Solvent | Predicate Device 20% Citric Acid Irrigant | Reference Device EDS Combo-Rinse | Reference Device Endocyn Root Canal Irrigation Solution | | Principle of Operation | formulated to dissolve inorganic materials from root canal walls | smear layer removal via chelation | | | | Application method | Filled into syringes and delivered via choice of dental irrigation tip | Filled into syringes and delivered via choice of dental irrigation tip | Filled into syringes and delivered via choice of dental irrigation tip | Filled into syringes and delivered via choice of dental irrigation tip | | Packaging & Storage | • 4 oz (118mL) refill bottle, no special storage conditions. | • 30 mL refill syringe, no special storage conditions. | • Bottle | • Bottle | | Nature of Body Contact (ISO 7405:2018) | External communicating device with limited (≤24 hour) contact time | External communicating device with limited (≤24 hour) contact time | External communicating device with limited (≤24 hour) contact time | External communicating device with limited (≤24 hour) 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 | | Cytotoxicity Testing / Analysis Performed | All components that make patient contact have been evaluated according to ISO 7405 / | Meets Requirements | Meets Requirements | Meets Requirements | | | Proposed Device Sealer Solvent | Predicate Device 20% Citric Acid Irrigant | Reference Device EDS Combo-Rinse | Reference Device Endocyn Root Canal Irrigation Solution | | Prescription / OTC | Prescription | Prescription | Prescription | Prescription | | Standards | ISO 7405:2018 ISO 10993-1:2018 ISO 10993-5:2009 ISO 14971:2019 ISO 15223-1:2021 ISO 11014:2009 ISO 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 used in dentistry | | ISO 10993-1:2018 | Biological evaluation of medical devices | | ISO 10993-5:2009 | Biological evaluation of medical devices Part 5 -Tests for in vitro cytotoxicity | | ISO 14971:2019 | Application of Risk Management to Medical Devices | | ISO 15223-1:2021 | Symbols to be used with information to be supplied by the manufacturer | | ISO 11014:2009 | Safety data sheet for chemical products | | ISO 20417:2021 | Medical devices Information 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%.