Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. It contains an organic salt that reacts with the 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.

AI/ML Overview

The provided document describes the Super Seal® Tooth Desensitizer (K120109), which is a tooth desensitizer intended to aid in the relief from dentinal sensitivity.

Here is an analysis of the acceptance criteria and the studies that prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance and Evidence
Primary Mechanism of Action: Occlude dentinal tubules, blocking fluid flow.	Evidence:- Kolker et al. (in-vitro study): Evaluated the effect on permeability, hydraulic conductance, and morphological tubule change. Showed "a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®."- Suzaki et al. (follow-up study): "confirming tubule occlusion."- Duran et al. (study on HEMA products, cited for comparison): Showed a decrease in permeability by tubule occlusion for HEMA based products (this offers context for the concept of tubule occlusion as a mechanism, though Super Seal® is described as having a different chemical mechanism than HEMA products).Reported Performance: The device's technological characteristic section explicitly states, "Super Seal® Tooth Desensitizer ... reacts with the calcium hydroxyapatite of the surface and peritubular dentin to form calcium oxalate crystals occluding the tubules." The in-vitro studies confirm this functional occlusion.
Clinical Effectiveness: Aid in the relief from tooth sensitivity.	Evidence:- Suzaki et al. (in-vivo portion): "evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity." The specific measure of effectiveness (e.g., percentage reduction in sensitivity, duration of relief) is not detailed in the summary.
Safety: No adverse effects or safety issues.	Evidence:- Overall statement: "No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies."
Substantial Equivalence to Predicates:	Evidence:- The conclusion explicitly states, "From the nonclinical and clinical tests that were preformed we conclude that Super Seal® Tooth Desensitizer is substantially equivalent to the predicate devices." This implies that the performance in terms of mechanism, effectiveness, and safety is comparable to the predicate devices (Protect Tooth Desensitizer K050486 and Orajel Advanced Tooth Desensitizer K041680). The commonality in the mechanism discussed with predicates (occluding dentinal tubules) supports this.

2. Sample Size Used for the Test Set and Data Provenance

Suzaki et al. (in-vivo portion):
- Sample Size: 100 cases of human sensitivity.
- Data Provenance: Human sensitivity cases, implying a clinical study with patients. The country of origin is not specified, but it is an in-vivo study. It is implied to be a prospective study as it "evaluated 100 cases" to show effectiveness.
Kolker et al. and Suzaki et al. (in-vitro portions): The sample sizes for these in-vitro studies (permeability, hydraulic conductance, morphological tubule change, tubule occlusion) are not specified in the summary. Data provenance is implied to be laboratory research.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the summary. The studies mentioned (Kolker et al. and Suzaki et al.) would have involved researchers and clinicians, but the specific number and qualifications of experts for establishing ground truth (e.g., diagnosing sensitivity, assessing occlusion) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the summary. For in-vivo studies assessing patient hypersensitivity, expert assessment would typically be involved, but no specific adjudication method (like 2+1 or 3+1 consensus) is outlined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The studies mentioned focus on the performance and safety of Super Seal® itself, and its comparison to predicates for substantial equivalence. There is no mention of human readers or AI assistance in the context of this device. The device is a direct-application dental product, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (tooth desensitizer), not an algorithm or AI system. Therefore, the concept of a "standalone" algorithm performance study does not apply.

7. The Type of Ground Truth Used

In-vitro studies (Kolker et al. & Suzaki et al. on occlusion/permeability): Ground truth was likely established through objective laboratory measurements (e.g., permeability measurements, microscopic analysis of tubule occlusion).
In-vivo study (Suzaki et al. on human sensitivity): Ground truth for "patient hypersensitivity" would have been based on patient reported symptoms or clinical assessment of sensitivity, likely by a dentist or dental professional. Outcomes data (relief from sensitivity) served as the measure of effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/algorithm that requires a training set. The term "training set" doesn't apply in the context of conventional medical device performance studies for a topical treatment.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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KI20109

MAR - 7 2012

510(k) Summary

Date:	1/12/12
Submission:	Traditional Premarket Notification 510(k) Submission (21CFR 807.90(e)) for a new OTC medical device.
Company:	Phoenix Dental, Inc.
Contact:	Jeffrey S. Cox, President/CEO
Address:	3452 West Thompson Rd.
City, State, Zip:	Fenton, MI 48430
Phone:	(810)750-2328
Fax:	(810)750-7495
Email:	jeffreycox@phoenixdental.com
Trade Name:	Super Seal® Tooth Desensitizer
Common Name:	Tooth Desensitizer
Panel:	Dental
Device Class:	Class II
Product Code:	LBH
Classification:	Varnish, Cavity
Substantially Equivalent:	Protect Tooth Desensitizer
	LBH, Varnish, Cavity
	K050486
	Orajel Advanced Tooth Desensitizer
	KLE, Agent, Tooth Bonding, Resin
	K041680
Device Description:	Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in

dentinal sensitivity. It contains an organic salt that reacts with the 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.

Intended Use: Single application to aid in the relief from tooth sensitivity.

Indications for Use: To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.

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Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be "K120109". The characters are written in black ink on a white background. The handwriting is somewhat messy and the characters are not perfectly formed.

Technological Characteristics: Super Seal® Tooth Desensitizer as well as both predicates occlude the dentinal tubules blocking fluid flow of the dentinal complex. However, Super Seal® Tooth Desensitizer technology differs from the predicates because they place a layer that covers the tooth's surface occluding the tubules; while Super Seal® Tooth Desensitizer reacts with the calcium hydroxyapatite of the surface and peritubular dentin to form calcium oxalate crystals occluding the tubules.

Performance Data: The in-vitro Kolker et al. study evaluated the effect on permeability, hydraulic conductance and morphological tubule change. Kolker et al. showed a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®. A follow up study was performed by Suzaki et al. confirming tubule occlusion. Duran et al. study showed a decrease in permeability by tubule occlusion for HEMA based products.

Suzaki et al., in-vivo portion of their study evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity. No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies.

Conclusion:

From the nonclinical and clinical tests that were preformed we conclude that Super Seal® Tooth Desensitizer is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jeffrey S. Cox President / CEO Phoenix Dental, Inc. 3452 West Thompson Road Fenton, Michigan 48430

MAR - 7 2012

Re: K120109

Trade/Device Name: Super Seal® Tooth Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 14, 2012 Received: February 15, 2012

Dear Mr. Cox:

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. 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.

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Page 2 - Mr. Cox

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compriset notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

h foc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices. Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number: K120109

Device Name: Super Seal® Tooth Desensitizer

Indications for Use of Super Seal® Tooth Desensitizer

To aid in the relief from dentinal sensitivity .
This could be caused by: ●
- o Cold
- o Heat ·
- o Acids
- Sweets o
- Result from dental whitening agents O

Prescription Use __

AND/OR Over-The-Counter Use_

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D) .

Wagi links

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

510(k) Number: K120109

Revision Number: 3 Revision Date: 3/6/12

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.