Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

Device Description

Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for Oralief™ Therapy for Sensitive Teeth. This product is a dentifrice (toothpaste) containing NovaMin® as its active ingredient, intended to provide relief from tooth hypersensitivity by occluding dentin tubules.

Here's an analysis based on the provided text, addressing your questions:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a predefined threshold for statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criterion for the device seems to be demonstrated efficacy in reducing tooth hypersensitivity compared to a placebo, and substantial equivalence to a legally marketed predicate device (Butler GUM® Prophylaxis Paste with NovaMin®).

The reported device performance is based on the clinical study described.

Acceptance Criterion (Implicit)	Reported Device Performance
Demonstrated Efficacy in Reducing Tooth Hypersensitivity	- Rapid and continual relief: Statistically significant reduction in VAS score for NovaMin® group compared to placebo (p < .001 for treatment effect over time).- Early onset of effect: NovaMin® group showed statistical decline in VAS score at each time point.- Sustained effect: NovaMin® VAS at week 2 = 2.85 ± 1.52 vs. Placebo VAS = 5.91 ± 0.92 (p < 0.01). (This is a snapshot, but the "continual relief" is implied by the sustained significant difference).
Biocompatibility/Safety	- No hazardous effects: Biocompatibility tests on NovaMin® indicated no evidence of hazardous effects when used as directed.- No adverse events: All patients completed the treatment course with no reported adverse events during the clinical study.
Tubule Occlusion Efficacy (in vitro)	- Significantly greater occlusion: Oralief™ occluded a significantly greater number of tubules compared to controls in an in vitro dentin block model. (While not a clinical "performance" directly, it supports the mechanism of action).
Substantial Equivalence to Predicate Device (K024343)	- Oralief™ has "very similar" technological characteristics to Butler GUM® Prophylaxis Paste with NovaMin®. Both use NovaMin® to produce a calcium phosphate layer for dentinal tubule occlusion. The primary differences are the regimen and application method, and minor ingredient proportion differences. This is a foundational regulatory criterion.

Study Details

Sample size used for the test set and the data provenance:
- Test set sample size: 20 patients were enrolled (10 in the NovaMin® group, 10 in the placebo group). A total of 48 sensitive teeth were measured in the NovaMin® group and 42 teeth in the placebo group.
- Data provenance: The study was conducted at the Dental School of the University of Bologna, Italy. It was a prospective, double-blinded, two-arm parallel group study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "ground truth" here is the patient's subjective experience of pain/hypersensitivity, measured using a Visual Analogue Scale (VAS). This is patient-reported, not expert-established in the traditional sense of diagnostic imaging.
- The study protocol was approved by the Ethics Committee at the Dental School of the University of Bologna, Italy, implying expert oversight of the study design and ethical conduct. However, experts did not "establish ground truth" for individual patient responses.
Adjudication method for the test set:
- Not applicable in the context of this study. The primary endpoint (VAS score) is a patient-reported outcome. There was no independent adjudication of patient responses. Measures included a metered air blast and cold water, which are objective stimuli, but the response (VAS score) is subjective.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a toothpaste for sensitive teeth, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a therapeutic product, not an algorithm. Its performance is evaluated through its direct effect on patients.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for efficacy was primarily patient-reported outcomes data (Visual Analogue Scale - VAS scores) in response to standardized stimuli (metered air blast and cold water).
- Additionally, in vitro studies demonstrated tubule occlusion, supporting the mechanism of action.
The sample size for the training set:
- Not applicable. This is a clinical trial for a therapeutic device, not a machine learning model. Therefore, there is no "training set" in that context. The "training" here refers to the development and formulation of the product.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the machine learning sense. The development of the product would have involved extensive R&D, chemical analysis, in vitro testing, and potentially pre-clinical animal studies, but not a "ground truth" derived from patient data in a training set.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Dr. David C. Greenspan Vice President & Chief Technology Officer NovaMin Technology, Incorporated 13709 Progress Boulevard #23 Alachua, Florida 32615

Re: K040858 Trade/Device Name: OraliefTM Therapy for Sensitive Teeth Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 18,2004 Received: August 19,2004

Dear Dr. Greenspan:

This letter corrects our substantially equivalent letter of September 02.2004. regarding the classification of your device which was incorrectly identified as "unclassified."

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 (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 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.

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

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Page 2 - Dr. David C. Greenspan

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 continue 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Chiu S. Lin, PhD

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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510(k) Premarket Notification NovaMiu Technology, Inc.
Orallef™ Therapy for Sensitive Tecth

510(k) Number (if known): K6_40X58

Device Name: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K040858

Prescription Use _ X

OR (Per 21 CFR 801,109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

SECTION D -- STATEMENT OF INDICATIONS FOR USE

Page 1)-1

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SEP - 2 2004

510(k) Premarket Notification NovaMin Technology, Inc. Oralicf™ Therapy for Sensitive Teeth

K040858

1. SUBMITTER INFORMATION:

Name:	NovaMin Technology, Inc.
Address:	13709 Progress Blvd., #23
	Alachua, Florida 32615 USA
Phone:	(386) 418-1551
Facsimile:	(386) 418-1465
Contact:	David C. Greenspan, Ph.D.

Preparation Date: April 1, 2004

2. DEVICE NOMENCLATURE:

Trade Name:	Oralief™ Therapy for Sensitive Teeth
Common Name:	Dentifrice; Toothpaste
Classification Name:	Agent, Polishing, Abrasive, Oral Cavity

3. LEGALLY MARKETED PREDICATE DEVICE:

Device Name:	Butler GUM® Prophylaxis Paste with NovaMin®
510(k) Number:	K024343
Applicant:	USBiomaterials Corporation

4. DEVICE DESCRIPTION:

5. INTENDED USE:

Clinical studies have shown that Oralief™ provides rapid and continual relief from tooth hypersensitivity due to cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

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6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of Oralief™ and Butler GUM® Prophylaxis Paste with NovaMin® are very similar. Both devices are designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface. Both devices use NovaMin" to produce a calcium phosphate layer that occludes dentinal tubules and blocks hydrodynamic flow. The primary difference between the two devices is that Oralief™ supplies the calcium and phosphate ions on a daily basis for two weeks, followed by a once a week maintenance brushing for twenty-four weeks, whereas Butler GUM® Prophylaxis Paste with NovaMin® supplies the ions once every professional tooth cleaning. Oralief™ is intended to be distributed by the professional in the dental office for home use by the patient, whereas Butler GUM® Prophylaxis Paste with NovaMin® is applied by the hygienist in the dental office. In addition, there are some differences in the proportion of the ingredients in the two products.

7. SAFETY AND PERFORMANCE DATA:

Many different biocompatibility tests have been performed on NovaMin®, the active ingredient in Oralief™. The results of these tests indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed.

The tubule occlusion efficacy of Oralief™ was evaluated using an in vitro dentin block model. The results indicate that Oralief™ occludes a significantly greater number of tubules when compared to controls.

A double-blinded, two-arm parallel group study was conducted to assess the efficacy of a 7.5% w/w NovaMin -containing toothpaste formulation in the reduction of tooth hypersensitivity. The study protocol was approved by the Ethics Committee at the Dental School of the University of Bologna, Italy. Two measures of sensitivity were used in the study; a metered air blast (one second duration) and cold water (3 ml at 4℃) delivered from a syringe. The time between measures on a given tooth was at least 3 minutes. Subjects were instructed to brush their teeth in their usual manner for one minute, brushing no more than a total of two times per day for two weeks. At the two-week appointment, patients were instructed to use the product only once a week for two additional weeks. A total of 20 patients were enrolled in the study, 10 in each group. A total of 48 sensitive teeth were measured in the NovaMin® toothpaste group and 42 teeth in the placebo group. There were no adverse events reported during the study. All patients completed the course of treatment.

A 2 (treatment) x 5 (time periods) repeated-measures ANOVA was conducted on the VAS score averaged across the cold water and air pressure methods. The results showed that there were significant effects of treatment (NovaMin® was statistically better at reducing sensitivity than placebo, p < . 001) and that the effects were statistically significant over the time periods as well (p < .001). Post hoc tests showed that there were no differences between the test and placebo group at baseline (NovaMin® mean VAS = 6.68 ±0.88, Placebo = 6.37 ± 1.05), but that the test group was statistically better at each time point than the placebo (NovaMin® VAS at week 2 = 2.85 ± 1.52, versus Placebo VAS = 5.91 ±0.92, p < 0.01). The test group showed statistical decline in VAS score at each time point, and the placebo only showed a statistical decrease at the 3-week (p < . 02 ) and 4week (p < . 017) time periods versus baseline. The results of this study demonstrated that the 7.5% w/w NovaMin -containing formulation provided rapid and continual relief from tooth hypersensitivity.

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8. CONCLUSIONS:

Oralief™ is considered to be substantially equivalent to the legally marketed predicate device, Butler GUM® Prophylaxis Paste with NovaMin® (K024343). The provided clinical study and biocompatibility data demonstrate the safety and efficacy of Oralief™ for the intended use.

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Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Dr. David C. Greenspan Vice President & Chief Technology Officer NovaMin Technology, Incorporated 13709 Progress Boulevard #23 Alachua, Florida 32615

Dear Dr. Greenspan:

This letter corrects our substantially equivalent letter of September 02.2004. regarding the classification of your device which was incorrectly identified as "unclassified."

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Page 2 - Dr. David C. Greenspan

Sincerely yours,

Chiu S. Lin, PhD

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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510(k) Premarket Notification NovaMiu Technology, Inc.
Orallef™ Therapy for Sensitive Tecth

510(k) Number (if known): K6_40X58

Device Name: _________________________________________________________________________________________________________________________________________________________________

INDICATIONS FOR USE:

Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:	K040858

Prescription Use _ X

OR (Per 21 CFR 801,109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

SECTION D -- STATEMENT OF INDICATIONS FOR USE

Page 1)-1

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SEP - 2 2004

510(k) Premarket Notification NovaMin Technology, Inc. Oralicf™ Therapy for Sensitive Teeth

K040858

1. SUBMITTER INFORMATION:

Name:	NovaMin Technology, Inc.
Address:	13709 Progress Blvd., #23
	Alachua, Florida 32615 USA
Phone:	(386) 418-1551
Facsimile:	(386) 418-1465
Contact:	David C. Greenspan, Ph.D.

Preparation Date: April 1, 2004

2. DEVICE NOMENCLATURE:

Trade Name:	Oralief™ Therapy for Sensitive Teeth
Common Name:	Dentifrice; Toothpaste
Classification Name:	Agent, Polishing, Abrasive, Oral Cavity

3. LEGALLY MARKETED PREDICATE DEVICE:

Device Name:	Butler GUM® Prophylaxis Paste with NovaMin®
510(k) Number:	K024343
Applicant:	USBiomaterials Corporation

4. DEVICE DESCRIPTION:

5. INTENDED USE:

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6. TECHNOLOGICAL CHARACTERISTICS:

7. SAFETY AND PERFORMANCE DATA:

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8. CONCLUSIONS:

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.