Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and physical properties of the gel and its effect on tooth structure, with no mention of AI or ML.

Therapeutic

Yes.
The device's intended use is "To relieve dental hypersensitivity," which is a therapeutic purpose. It directly treats a condition by remineralizing teeth, occluding tubules, and blocking nerve excitability.

Diagnostic

No

Explanation: The device description and intended use clearly state that ReminGel is a treatment for dental hypersensitivity, focusing on remineralization and blocking fluid flow and nerve excitability. There is no mention of it being used to diagnose conditions or process diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states that ReminGel is an "opaque aqueous-based gel" consisting of suspended hydroxyapatite and calcium and phosphate salts, which are physical substances. It is packaged in a tube and applied using dental appliances or a toothbrush. This indicates a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to relieve dental hypersensitivity by acting directly on the tooth structure (remineralization and tubule occlusion) and potentially nerve excitability. This is a therapeutic action within the body, not a diagnostic test performed on a sample taken from the body.
Device Description: The description details a gel applied to the teeth, which is consistent with a topical therapeutic device, not a diagnostic reagent or instrument.
Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, urine, saliva, etc.) to diagnose a condition or provide information about a patient's health status. The device's action is directly on the affected tissue.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.

Product codes

LBH

Device Description

ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release.
ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-thecounter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Non-Clinical Performance Testing and Compliance:

Tubule Occlusion Testing: An in vitro tubule occlusion study was performed on resected human teeth using ReminGel and Super Seal. Identical to the predicate device (Super Seal), ReminGel visibly occluded dentinal tubules demonstrating that the product will inhibit dentin sensitivity.
Shelf-Life Testing: Through accelerated shelf life testing, ReminGel was found to have a shelf-life of two years. Real time aging is being performed on ReminGel to support shelf life during typical storage conditions.
Transit Testing: This test confirms that the packaging configurations are sufficient and withstand simulated transit conditions. Moreover, the products performed satisfactory post-transit, which confirms that transit did not have a negative effect on the products themselves.
Cytotoxicity Testing: ReminGel was found to yield better cytotoxicity results compared to the predicate device, SuperSeal.
Irritation Testing: ReminGel was found to be a non-irritant.
Sensitization Testing: ReminGel was found to be a non-sensitizing agent.

Clinical Performance Testing and Compliance:
Clinical performance is not deemed necessary.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120109

Reference Device(s)

K120176

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 8, 2025

Inter-Med. Inc. Alex Johnson VP of Engineering, Regulatory & Quality 2200 South Street Racine, Wisconsin 53404

Re: K241489

Trade/Device Name: ReminGel Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: LBH Dated: December 9, 2024 Received: December 9, 2024

Dear Alex Johnson:

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.

1

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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

2

assistance/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 -S

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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Submission Number (if known)

K241489

Device Name

ReminGel

Indications for Use (Describe)

To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X 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 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/4/Picture/1 description: The image shows the logo for Vista Dental Products. The logo features the word "VISTA" in a sans-serif font, with a stylized mountain range above it. Below the word "VISTA" are the words "Dental Products" in a smaller font. The logo is primarily blue and black.

510(k) Summary for K241489 – ReminGel

1. Applicant

-------------------	---------------------------------	------------------------	-------------------

Address: Inter-Med, Inc. / Vista Apex 2200 South St. Racine, WI, USA 53404

Contact Person: Alex Johnson, MSc

Email: ajohnson@vista-dental.com

Phone: (262) 631-5306

Fax: (262) 636-9760

2. Device Name

Proprietary Name: ReminGel Common Name: Varnish, Cavity Classification Name: Cavity Varnish Product Code: LBH Device Class: Class 2

3. Predicate Device

Primary Predicate Device Super Seal (K120109) by Phoenix Dental Inc.

Common Name: Varnish, Cavity O
Classification Name: Cavity Varnish o
Product Code: LBH O
Device Class: Class 2 O

Reference Device Senzzzzz Away (K120176) by Centrix, Inc.

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Image /page/5/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, and to the right of the globe is the word "INC." in black.

Image /page/5/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 TM symbol next to it. Below "VISTA" are the words "Dental Products" in a smaller font.

Common Name: Varnish, Cavity о
Classification Name: Cavity Varnish O
Product Code: LBH O
Device Class: Class 2 o

4. Device Description

ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release.

ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-thecounter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.

This is the only 510(k) for this medical device, no prior 510(k)s have been submitted.

ર. Intended Use / Indication for Use

To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or ● sweets.

Technological Characteristics and Substantial Equivalence 6.

Characteristics	Proposed Device	Predicate Device	Reference Device
Trade Name	ReminGel	Super Seal	Senzzzzzz Away
Or D/Sense Crystal
Common name	Varnish, Cavity	Varnish, Cavity	Varnish, Cavity
Classification
name	Cavity Varnish	Cavity Varnish	Cavity Varnish
Manufacturer	Inter-Med, Inc. / Vista Apex	Phoenix Dental Inc.	Centrix, Inc.
510(K) number	K241489	K120109	K120176
Product code	LBH	LBH	LBH
Device
Description	ReminGel is a convenient,
premixed, ready-to-use,
opaque aqueous-based gel.
ReminGel consists of	Super Seal Tooth
Desensitizer is applied
with an applicator by the
use to aid in dentinal	Senzzzzz Away is an
oxalate tooth desensitizing
agent intended for over-the-
counter-use. The
Characteristics	Proposed Device	Predicate Device	Reference Device
	suspended hydroxyapatite
and calcium and phosphate
salts that help restore a
tooth's hydroxyapatite
structure through
remineralization. This
remineralization results in
tubule occlusion and blocks
fluid flow in dentinal
tubules, thereby relieving
dentinal sensitivity.
Additionally, ReminGel
blocks nerve excitability
through potassium release.	sensitivity. It contains an
organic salt that reacts
with calcium
hydroxyapatite in the
dentinal tubules. The
formation of these calcium
oxalate crystals inhibits
and blocks fluid flow in
the tubules, thereby
relieving dentinal
sensitivity.	combination of tubule
occlusion and reduction in
nerve excitability shown
with oxalate formulations is
responsible for the reduction
in dentinal hypersensitivity
to cold, hot and sweets.
Senzzzzz Away is a one-
part, opaque gel for single
use.
Indication for use
/ intended use	To relieve dental
hypersensitivity caused by
bleaching procedures, cold,
heat, acids, or sweets.	To aid in the relief from
dentinal sensitivity caused
by cold, heat, acids,
sweets, or as the result
from dental whitening
agents.	To relieve dental
hypersensitivity.
Packaging	ReminGel is packaged in a
3oz (90mL) tube. The tube
of ReminGel is placed into a
printed cardboard bearing
instructions for use and
appropriate labeling.	Super Seal is packaged in
plastic bottles containing 8
mL with instructions for
use.	Senzzzzz Away is packaged
in one multi-use vial with
two reusable brushes.
Years on the
Market	-	12 years	12 years
Intended
Population	Patients with dentinal
sensitivity	Patients with dentinal
sensitivity	Patients with dentinal
sensitivity
Delivery Form	ReminGel can be applied to
teeth using dental
appliances (e.g. fluoride
tray, whitening tray,
periotray, etc.) or via a
toothbrush.	Product placed direct onto
affected area using cotton
pellet or microsponge.	Product placed direct onto
affected area

Mechanism of
Action / Principle
of Operation	Tubule occlusion

Physical occlusion of
dentinal tubules by forming
hydroxyapatite.
Additionally, ReminGel
blocks nerve excitability
through potassium release. | Tubule occlusion

Physical occlusion of
dentinal tubules by
forming oxalate
precipitates and block
neural transmission
through potassium ion
release. | Tubule occlusion

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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 line underneath it. 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/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 "VISTA" is the text "Dental Products" in a smaller font. The logo is simple and clean, with a focus on the company name and the dental industry.

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, and to the right of the globe is the word "INC." in black.

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 blue sans-serif font. The letters are connected by a blue line. The words "Dental Products" are written in a smaller, black sans-serif font below the word "VISTA". There is a black line under the word "VISTA".

Similarities between the subject device (ReminGel) and the predicate and reference device (Super Seal and Senzzz Away, respectively).

ReminGel has nearly identical indications for use as its predicate device (Super Seal); the only ● differences are nuanced descriptions for "bleaching" versus "whitening".
ReminGel is classified under product code LBH, with respect to 21 CFR 872.3260 and the ● common name "Cavity Varnish", which is identical to that of the predicate device (Super Seal) and reference device (Senzzz Away).
ReminGel has identical intended population use as the predicate device (Super Seal) and ● reference device (Senzzz Away) and is used in the same anatomical location.
Identical to the predicate device (Super Seal) and reference device (Senzzz Away), ReminGel is a single component product.
ReminGel uses a similar mechanism of action to relieve dental hypersensitivity (i.e. dentinal ● occlusion) compared to the predicate device (Super Seal) and the reference device (Senzzz Away).

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Image /page/8/Picture/0 description: The image shows the logo for Intermed INC. The word "intermed" is in blue, with a black line underneath it. 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/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 "VISTA" is the text "Dental Products" in a smaller font. There is a horizontal line below the text.

The minor difference in mechanism of action between the use of hydroxyapatite O formation and oxalate precipitate does not raise concern and the subject device remains substantially equivalent.
ReminGel has an application time which is similar to the predicate device (Super Seal) and reference device (Senzzz Away). Because ReminGel helps remineralize dentin with its constituents, the nature of body contact classification is external communicating device with permanent contact with tissue/bone/dentin, which is equivalent to the predicate device (Super Seal) and reference device (Senzzz Away).
- The minor difference in application time between minutes and seconds does not raise O concern since the precipitate formation is slightly different and ReminGel has been deemed safe and effective for its intended use.
ReminGel composition contains a potassium salt which is identical to the predicate device ● (Super Seal) and reference device (Senzzz Away).
- The difference in composition such as other ionic salts, sweetener, flavoring, and O thickeners do not raise concern since the precipitate formation is slightly different and biocompatibility testing confirms the product is biocompatible for its intended use.
ReminGel's shelf life of two years is identical to the predicate device (Super Seal) and ● reference device (Senzzz Away).
Identical to the predicate device (Super Seal) and reference device (Senzzz Away), ReminGel . is an aqueous-based material and is commercialized non-sterile.
Identical to the reference device (Senzzz Away), ReminGel is for prescription use (Rx) and . over-the-counter use (OTC).

ReminGel shares similar intended use, technical characteristics, and composition to the predicate and reference devices. Therefore, ReminGel is substantially equivalent to the predicate device and poses no additional safety or efficacy risks.

Discussion of Differences between the subject device (ReminGel) and the predicate and reference device (Super Seal and Senzzz Away, respectively)

. The formulation of ReminGel is different than the predicate device (Super Seal) and reference device (Senzzz Away). Specifically, ReminGel contains other ingredients (salts, buffering agents, pH modifier, sweetener, flavoring) that are not explicitly present in the predicate device or reference device.
- The difference in composition such as other ionic salts, sweetener, flavoring, and o thickeners do not raise concern since the precipitate formation is slightly different and biocompatibility testing confirms the product is biocompatible for its intended use. Additionally, the sweetener and flavoring is added for user satisfaction.
- Therefore, the subject device remains substantially equivalent to its predicate device. O
ReminGel is applied using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush, whereas the predicate device (Super Seal) is applied directly to the affected area

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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 light blue sans-serif font. To the right of the word "VISTA" is the trademark symbol. Below the word "VISTA" are the words "Dental Products" in a smaller, darker font.

using a cotton pellet or microsponge and the reference device (Senzzz Away) is applied directly to the affected area.

This difference does not raise any significant concerns as the ReminGel was confirmed to O be biocompatible as the device passed relevant tests within ISO 7405:2018.
Therefore, the subject device remains substantially equivalent to its predicate device. O
ReminGel is packaged in a plastic 3oz (90mL) tube as compared to an 8mL bottle (predicate ● device. Super Seal) or multi-use vial (reference device. Senzzz Away).
- This difference does not raise any significant concerns as it is simply a volume difference O offered to users. Additionally, the medical devices are applied in slightly different techniques resulting in different package volumes.
ReminGel is for prescription use (Rx) and over-the-counter use (OTC), whereas the predicate device (Super Seal) is for prescription use (Rx) only.
- Reference is made to the reference device (Senzzz Away) which is for prescription use o (Rx) and over-the-counter use (OTC) and bears many similarities to the subject device as discussed in the previous section.

Applicable Standards

ISO 7405:2018 Dentistry Evaluation of Biocompatibility of Medical Devices Used in Dentistry ●
ISO 10993-1:2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing ● within a Risk Management Process
ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro ● Cytotoxicity
ISO 10993-10:2021 - Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
ISO 10993-23:2021 Biological Evaluation of Medical Devices Part 23: Tests for Irritation ●
ISO 14971:2019 Application of Risk Management to Medical Devices ●
ISO 15233-1:2021 - Symbols to be used with Information to be Supplied by the Manufacturer -Part 1: General Requirements
ISO 11014:2009 - Safety Data Sheet for Chemical Products
ISO 20417:2021 Information to be Supplied by the Manufacturer

7. Non-Clinical Performance Testing and Compliance

The following non-clinical tests were conducted to evaluate the functionality, performance, safety, and substantial equivalence of ReminGel to Super Seal:

Tubule Occlusion Testing ●
- o An in vitro tubule occlusion study was performed on resected human teeth using ReminGel and Super Seal. Identical to the predicate device (Super Seal), ReminGel

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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 black line underneath. To the right of the word is a blue globe with white lines, and 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 a large, sans-serif font. Below "VISTA" is the phrase "Dental Products" in a smaller font. There is a horizontal line below the word "VISTA".

visibly occluded dentinal tubules demonstrating that the product will inhibit dentin sensitivity.

Shelf-Life Testing
- Through accelerated shelf life testing, ReminGel was found to have a shelf-life of two O years. Real time aging is being performed on ReminGel to support shelf life during typical storage conditions.
Transit Testing ●
- o This test confirms that the packaging configurations are sufficient and withstand simulated transit conditions. Moreover, the products performed satisfactory post-transit, which confirms that transit did not have a negative effect on the products themselves.
Cytotoxicity Testing ●
- ReminGel was found to yield better cytotoxicity results compared to the predicate о device, SuperSeal.
Irritation Testing ●
- ReminGel was found to be a non-irritant. o
Sensitization Testing
- ReminGel was found to be a non-sensitizing agent. o

8. Clinical Performance Testing and Compliance

Clinical performance is not deemed necessary.

9. Conclusion

ReminGel is to be marketed by Inter-Med. Inc., 2200 South St., Racine, WI 53404, and is substantially equivalent to Super Seal (K120109). The subject medical device has a nearly identical intended use and technological characteristics as the predicate device. Any differences between the subject medical device and predicate medical device do not sigmificantly alter the product's use and do not result in unacceptable or unnecessary risks to the patients or users. Therefore, Inter-Med concludes that ReminGel is substantially equivalent to the predicate device, Super Seal, and the product is safe and effective for its intended use.