(106 days)
No
The device description and performance studies focus on the chemical and physical properties of a root canal cleanser, with no mention of AI or ML technologies.
No
The device is described as a root canal cleanser intended to irrigate, cleanse, and debride root canal systems. While it aids in treatment, it does not directly treat or cure a disease or condition itself, but rather facilitates the removal of materials during a therapeutic procedure. Its function is to dissolve and flush out substances, acting as an aid rather than a primary therapeutic agent.
No
The device is a root canal cleanser and irrigant. Its intended use is to remove foreign material, debris, and to soften/dissolve sealers, not to diagnose a condition.
No
The device description clearly states it is an "aqueous-based irrigant that is delivered via syringe and needle tip," indicating it is a liquid substance and associated hardware for delivery, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "irrigate, cleanse, and debride root canal systems," which is a direct therapeutic action within the body (specifically, the oral cavity/isolated tooth).
- Device Description: The description reinforces its use as an "irrigant" delivered via syringe and needle tip to soften and dissolve material within the root canal. This is a physical/chemical action performed on the patient's tooth structure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, collect a sample for analysis, or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies listed (dissolution, in-vitro canal performance, shelf-life, biocompatibility, cytotoxicity, anti-microbial, transit) are typical for a device that interacts directly with the body or is used in a clinical procedure, not for an IVD which would focus on analytical performance and clinical validity of diagnostic results.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KJJ
Device Description
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.
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 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 ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
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: 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).
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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) |
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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 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 | | | | | |
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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.
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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 |
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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
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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%.