Remesense is intended for the local management of dental sensitivity by patient application of foam strips impregnated with desensitizing gel.
Remesense is indicated for use as a tooth desensitizer.

Device Description

Remesense consists of a tray and impregnated foam strips. The Remesense foam strips are thin flexible foam strips, impregnated with a desensitizing liquid. These strips are designed to relieve dental (hyper) sensitivity by patient application to the affected tooth (teeth). The impregnated foam strips are held in place with trays.

AI/ML Overview

Here's an analysis of the provided text regarding the Remesense device, focusing on the acceptance criteria and study information:

The provided 510(k) summary for K082594 for the Remesense device does not contain any information about acceptance criteria or a study proving the device meets those criteria.

This is a common characteristic of 510(k) submissions for devices seeking substantial equivalence to a predicate device. The primary objective of these submissions is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than to prove its performance against specific acceptance criteria through a clinical or performance study.

Therefore, many of the requested elements for a study design and results cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
Any device-specific performance metric for desensitization	Not provided	Not provided

Explanation: The document does not specify any quantitative or qualitative acceptance criteria related to the device's efficacy in tooth desensitization, nor does it report any performance data from a study against such criteria. The submission is focused on demonstrating substantial equivalence based on technological characteristics and intended use.

Regarding the Study (if one were present):

Since no specific study proving the device meets acceptance criteria is described, the following points cannot be addressed from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, no study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no study described.
4. Adjudication method for the test set: Not applicable, no study described.
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 device is a dental product, not an AI diagnostic tool, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a dental product, not an algorithm.
7. The type of ground truth used: Not applicable, no study described.
8. The sample size for the training set: Not applicable, no study described.
9. How the ground truth for the training set was established: Not applicable, no study described.

Additional Information from the 510(k) Summary:

While not directly about acceptance criteria or a performance study, the document does provide information relevant to the device's regulatory pathway:

Substantial Equivalence: The primary conclusion is that "The information discussed above demonstrates that the Remesense device is substantially equivalent to the predicate devices." This is the basis for its clearance, not necessarily a direct demonstration of meeting pre-defined acceptance criteria through a new study.
Predicate Devices: The submission relies on comparison to predicate devices, including UltraEZ (K061438), Orajel (K041680), SuperSeal (K983477), and Provident (K073061). The comparison table highlights similarities in indications for use (tooth desensitizer), mode of action (tubule occlusion), and often material composition (Potassium Oxalate for Remesense and Superseal).
Technological Characteristics: The summary describes the mechanism of action: "Potassium oxalate breaks down into potassium and oxalic acid. The oxalic acid reacts with calcium ions to form calcium-oxalate crystals. These crystals block the dentin tubules, thereby alleviating dental sensitivity." This is presented as a "commonly used" method.

In summary, for this particular 510(k) submission, the "study" proving the device's suitability is the comparison to already-marketed predicate devices, demonstrating substantial equivalence in technology, intended use, and safety/effectiveness, rather than a de novo clinical trial with specific performance acceptance criteria.

Summary

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KO82594

510(k) Summary

Submitter Name:	Remedent NV
Submitter Address:	Xavier de Cocklaan 42Deurle, BELGIUM B-9831
Phone Number:	603 369 3550
Fax Number:	603 369 3562
Contact Person:	William Greenrose
Date Prepared:	02 September 2008
Device Trade Name:	Remesense
Common Name	Tooth Desensitizer
Classification Name:	Cavity Varnish
Number:	872.5260
Product Code:	LBH
Predicate Devices:	K061438 - UltraEZ, K041680 - Orajel, K983477 - SuperSeal, K073061 -Provident (details in table below)
Device Descriptionand Statement ofIntended Use	Device Description: Remesense consists of a tray and impregnatedfoam strips. The Remesense foam strips are thin flexible foam strips,impregnated with a desensitizing liquid. These strips are designed torelieve dental (hyper) sensitivity by patient application to the affectedtooth (teeth). The impregnated foam strips are held in place with trays.Statement of Intended Use: Remesense is intended for the localmanagement of dental sensitivity by patient application of foam stripsimpregnated with desensitizing gel.
Summary ofTechnologicalCharacteristics	Potassium oxalate breaks down into potassium and oxalic acid. Theoxalic acid reacts with calcium ions to form calcium-oxalate crystals.These crystals block the dentin tubules, thereby alleviating dentalsensitivity. Blockage of dentin tubules is commonly used by many toothsensitivity agents to reduce tooth sensitivity, and potassium oxalate is acommon material used to block dentin tubules.

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Submitter:Remedent	RemesensePremarket Notification: Traditional 510(k)		K082594
Conclusion	The information discussed above demonstrates that the Remesensedevice is substantially equivalent to the predicate devices
Declarations	This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information.

் This summary does not contain any patient identification information.

Feature	Remesense	UltraEZ	Orajel	Superseal	Provident
510(k) Number	TBD	K061438	K041680	K983477	K073061
Manufacturer	Remedent	UltradentProducts, Inc.	DELPharmaceuticals,Inc.	Phoenix Dental,Inc.	Coll Partners, Ltd.
Classification # &Product Code	872.3260LBH	872.3260LBH	872.3200KLE	872.3250EJK	872.3260LBH
ClassificationName	Cavity Varnish	Cavity Varnish	Tooth bondingresin agent	Calciumhydroxide cavityliner	Cavity Varnish
Common Name	ToothDesensitizer	ToothDesensitizer	ToothDesensitizer	ToothDesensitizer	ToothDesensitizer
Indications forUse	ToothDesensitizer	Provides a filmlike varnish forexposed teethsealing dentinaltubules of overexposed dentin orother exposedareas wherepostoperative orother dentinsensitivity is aconcern.	ToothDesensitizer	A potassiumoxalate based filmforming acidresistant liner anddesensitizer thatis indicated forapplication priorto restoration ofexposed dentin.	A fluoridecontaining varnishsystem intendedfor use as adesensitizingagent on thesurface areas ofhypersensitive orpotentiallysensitive teeth.
Mode of Action	TubuleOcclusion	TubuleOcclusion	TubuleOcclusion	TubuleOcclusion	TubuleOcclusion
MaterialComposition	PotassiumOxalate	KNO3 and KF	2-hydroxyethylmethacrylate	PotassiumOxalate	KF
Application	Tray/Kit/Gel	Gel	Liquid w/Swab	Gel	Tray/Kit/Gel
Rx/OTC	Rx	Rx	Rx	Rx	Rx

Summary of Technical Characteristics

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Remedent NV C/o Mr. William Greenrose President Qserve America, Incorporated 220 River Road Claremont, New Hampshire 03743-5567

Re: K082594

Trade/Device Name: Remesense Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: March 12, 2009 Received: March 17, 2009

Dear Mr. Greenrose:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Greenrose

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Lunnes

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.1 Indications for Use Statement

510(k) Number (if known):

K082594

Device Name: Remesense

Indications for Use:

Remesense is indicated for use as a tooth desensitizer.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription X Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Sussa Kumar

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082594

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.