Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules

Device Description

Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for Oralief™ OTC Toothpaste for Sensitive Teeth, structured to address your specific points:

Since this is a submission for a toothpaste (a medical device in this context), the "acceptance criteria" and "performance" are typically measured against established safety standards (like abrasivity limits) and functional claims (like tubule occlusion efficacy), rather than diagnostic accuracy metrics. There isn't a direct "acceptance criteria" table in the form you might expect for a diagnostic AI device, so I will synthesize it from the provided safety and performance data.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Performance Claim	Reported Device Performance
Safety - Biocompatibility	No evidence of any hazardous effects to the patient if the product is used as directed.
Safety - Abrasivity (RDA Value)	Mean Radioactive Dentin Abrasion (RDA) value of 125.55.
- Acceptable Limit (Implicit)	< 250 (considered safe for daily-use).
Efficacy - Dentin Tubule Occlusion	Occludes a statistically significant number of tubules when compared to controls.
Composition/Action Equivalence	Identical to the predicate device Oralief™ Therapy for Sensitive Teeth (K040858).
Intended Use	Fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set:
- Biocompatibility: Not specified. "Many different biocompatibility tests have been performed on NovaMin."
- Dentin Tubule Occlusion (in vitro): Not specified.
- Abrasivity (RDA): Not specified (implied to be standard for ADA procedure, but the exact number of samples or teeth is not given).
Data Provenance:
- Abrasivity (RDA): Evaluated at Indiana University School of Dentistry (USA). This suggests the study was conducted in the USA.
- Biocompatibility & Tubule Occlusion: Location of testing and specific methodology are not detailed, so provenance is unclear beyond being part of the submission process by NovaMin Technology, Inc. (USA).
Retrospective or Prospective: Unspecified for all studies. Given the nature of these tests (in vitro, lab testing), they are typically conducted as controlled prospective experiments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable in the context of this device. The device is a toothpaste (medical device), not an diagnostic AI system that requires expert interpretation for establishing ground truth on a test set of images or clinical cases. The "ground truth" here is based on objective scientific measurements and established laboratory procedures for biocompatibility, abrasivity, and physical occlusion.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable for this device submission. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing ground truth for diagnostic studies, especially in medical imaging. The studies described here are laboratory-based and measure physical properties or biological responses, not subjective interpretations.

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

This section is not applicable. An MRMC study is relevant for comparing the diagnostic performance of human readers, typically with and without AI assistance, on a set of clinical cases. This device is a toothpaste, not a diagnostic AI tool, so such a study would not be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. A "standalone" performance study refers to the performance of an algorithm independently of human input or interpretation. As this is a toothpaste, not an algorithm, this concept does not apply. The device's "standalone" performance in this context would be its inherent physical and chemical properties as measured in the lab.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the studies performed is based on:

Biocompatibility: Standardized in vitro and in vivo (though not explicitly detailed) tests designed to detect toxicity or adverse biological reactions. The "ground truth" is the observation of biological response (or lack thereof) against established safety thresholds.
Dentin Tubule Occlusion: Objective microscopic observation and quantification of occluded tubules in an in vitro dentin block model. The "ground truth" is the measurable physical blockage.
Abrasivity (RDA): Quantitative measurement of dentin wear using a standardized procedure (ADA recommended) involving radioactive dentin. The "ground truth" is the measured RDA value against a scientifically established safety limit.

8. The sample size for the training set

This section is not applicable. The concept of a "training set" is relevant for machine learning or AI models, where data is used to teach an algorithm. This device is a physical product (toothpaste), and its development does not involve machine learning in this documented context.

9. How the ground truth for the training set was established

This section is not applicable, as there is no "training set" for this device.

Summary

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1. SUBMITTER INFORMATION:

MAR 2 7 2008

Name:	NovaMin Technology, Inc.
Address:	13859 Progress Blvd., #600
	Alachua, Florida 32615 USA
Phone:	(386) 418-1551
Facsimile:	(386) 418-1465
Contact:	Robert G. Rothfritz

Preparation Date: January 9, 2008

2. DEVICE NOMENCLATURE:

Trade Name:	Oralief™ OTC Toothpaste for Sensitive Teeth
Common Name:	Dentifrice, Toothpaste
Classification Name:	Cavity Varnish (21 CFR 872.3260 Product Code LBH)

3. LEGALLY MARKETED PREDICATE DEVICE:

Device Name:	Oralief™ Therapy for Sensitive Teeth
510(k) Number:	K040858
Applicant:	NovaMin Technology, Inc.

4. DEVICE DESCRIPTION:

5. INTENDED USE:

Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that also provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules.

6. TECHNOLOGICAL CHARACTERISTICS:

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The technological characteristics of Oralief™ OTC Toothpaste for Sensitive Teeth are identical to the predicate device Oralief™ Therapy for Sensitive Teeth. Oralief™ OTC Toothpaste for Sensitive Teeth is designed to relieve hypersensitivity associated with exposed dentin by the deposition of a calcium phosphate layer onto the tooth surface that occludes dentinal tubules and blocks hydrodynamic flow.

7. SAFETY AND PERFORMANCE DATA:

Many different biocompatibility tests have been performed on NovaMin. 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™ OTC Toothpaste for Sensitive Teeth was evaluated using an in vitro dentin block model. The results indicate that Oralief™ OTC Toothpaste for Sensitive Teeth occludes a statistically significant number of tubules when compared to controls.

The relative abrasion level of Oralief™ OTC Toothpaste for Sensitive Teeth was evaluated at Indiana University School of Dentistry. The procedure used was the ADA recommended procedure for determination of toothpaste abrasivity. The result was a mean Radioactive Dentin Abrasion (RDA) value of 125.55. This RDA value is well under the limit considered safe for daily-use (RDA value < 250).

8. CONCLUSIONS:

Oralief™ OTC Toothpaste for Sensitive Teeth is considered to be substantially equivalent to the legally marketed predicate device, Oralief™ Therapy for Sensitive Teeth (K040858) because the compositions and actions are identical. The provided tubule occlusion studies, dentin abrasion study. and biocompatibility data demonstrate the safety and efficacy of Oralief™ OTC Toothpaste for Sensitive Teeth as a daily use toothpaste.

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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 features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2008

Mr. Robert G. Rothfritz Vice President, Operations NovaMin Technology, Incorporated 13859 Progress Boulevard, #600 Alachua, Florida 32615

Re: K080228

Trade/Device Name: Oralief" OTC Toothpaste for Sensitive Teeth Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 28, 2008 Received: January 30, 2008

Dear Mr. Rothfritz:

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. Rothfritz

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Sautte Y. Mckeen Omd

Chiu Lin, Ph.D. 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) Number (if known): K0806228

Oralief™ OTC Toothpaste for Sensitive Teeth Device Name:

INDICATIONS FOR USE:

Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kain Harley for MSR

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

510(k) Number:

SECTION D -STATEMENT OF INDICATIONS FOR USE

Page D-1

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.