Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Device Description

Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and 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

The information provided describes a 510(k) premarket notification for a dental device, focusing on its substantial equivalence to a predicate device rather than a new clinical study establishing specific acceptance criteria and performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, study design details, and performance metrics for a novel AI device is not available in the provided text.

Based on the provided information, here's what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The provided text does not present explicit numerical acceptance criteria for device performance as would be expected for a novel AI device. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device and showing efficacy in specific in vitro tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: No hazardous effects to the patient.	The results of cytotoxicity, intracutaneous irritation, maximization, and acute systemic toxicity tests indicate no evidence of any hazardous effects to the patient if the product is used as directed.
Tubule Occlusion Efficacy: Occlusion of exposed dentinal tubules.	An in vitro dentin block model study indicated that Butler Nucare® Root Conditioner with NovaMin® occludes a statistically significant number of tubules when compared with both positive and negative controls. (No specific percentage or quantitative measure is provided for the occlusion.)
Substantial Equivalence: Similar technological characteristics and intended use to predicate device.	The device is considered substantially equivalent to Quell™ Desensitizer (K010957). Both are designed to relieve hypersensitivity by depositing a calcium phosphate layer to occlude dentin tubules. Differences in the form of calcium/phosphate delivery (bioactive glass vs. solution) are noted.

Study Details (as far as available for this type of submission)

Sample size used for the test set and the data provenance:
- Biocompatibility Studies: Not specified, but standard in vivo and/or in vitro models would have been used for cytotoxicity, intracutaneous irritation, maximization, and acute systemic toxicity. Data provenance is not mentioned.
- Tubule Occlusion Efficacy Study: An "in vitro dentin block model" was used. The number of dentin blocks or samples is not specified. Data provenance is not mentioned. This is an in vitro study, not typically subject to geographical provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of submission. The studies described are laboratory-based (biocompatibility and in vitro efficacy), not involving expert-derived ground truth as in imaging or diagnostic AI.
Adjudication method for the test set:
- Not applicable. The reported studies are experimental measurements (e.g., cell viability for cytotoxicity, physical measurements for tubule occlusion), not requiring human adjudication.
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. This is not an AI device, and no MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance studies evaluate the physical and biological effects of the product itself.
The type of ground truth used:
- Biocompatibility: Measured biological endpoints (e.g., cell survival, skin reaction, systemic toxicity) based on established laboratory test methods.
- Tubule Occlusion Efficacy: Direct measurement of tubule occlusion in an in vitro model (e.g., microscopy). The "ground truth" here is the objective physical state of the tubules after treatment.
The sample size for the training set:
- Not applicable. This is not an AI device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K033295

OCT 2 8 2003

510(k) Premarket Norification NovaMin Technology, Inc. Butler Nucare® Root Conditioner with NovaMind

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.

September 2, 2003 Preparation Date:

2. DEVICE NOMENCLATURE:

Trade Name:	Butler Nucare ® Root Conditioner with NovaMin ®
Common Name:	Inorganic apatite-forming tooth root conditioner and dentin tubule occluder
Classification Name:	Cavity Varnish

3. LEGALLY MARKETED PREDICATE DEVICE:

Device Name:	QuelIT™ Desensitizer
510(k) Number:	K010957
Applicant:	Jeneric/Pentron, Inc.

4. DEVICE DESCRIPTION:

5. INTENDED USE:

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6. TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of Butler Nucare® Root Conditioner with NovaMin® and Quell™ Desensitizer are similar, but not identical. 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 are supplied in two phases that are rich in calcium and phosphate ions, which combine to produce a calcium phosphate layer that occludes and blocks hydrodynamic flow. The primary difference between the two devices is that Butler Nucare® Root Conditioner with NovaMin® supplies the calcium and phosphate ions in an aqueous suspension of bioactive glass, whereas Quell™ Desensitizer supplies the ions in an aqueous solution of calcium chloride and potassium phosphate.

7. SAFETY AND PERFORMANCE DATA:

The biocompatibility of Butler Nucare Root Conditioner with NovaMin® was evaluated for cytotoxicity (1 - 929), intracutaneous irritation, maximization, and acute systemic toxicity. 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 Butler Nucare Root Conditioner with NovaMin® was evaluated using an in vitro dentin block model. The results indicate that Butler Nucare® Root Conditioner with NovaMin® occludes a statistically significant number of tubules when compared with both positive and negative controls.

8. CONCLUSIONS:

Butler Nucare® Root Conditioner with NovaMin® is considered to be substantially equivalent to the legally marketed predicate device, Quell™ Desensitizer (K010957). The provided in vitro performance and biocompatibility data demonstrate the safety and efficacy of Butler Nucare® Root Conditioner with NovaMin for the intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2003

Mr. David C. Greenspan Responsible Third Party Official NovaMin Technology, Incorporated 13709 Progress Boulevard #23 Alachua, Florida 32615

Re: K033295

Trade/Device Name: Butler Nucare® Root Conditioner with NovaMin® Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 13, 2003 Received: October 14, 2003

Dear Mr. Greenspan:

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 vour 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. Greenspan

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely vours.

Clips
Elvira Luján, Ph.D.

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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OF INDICATION

510(k) Number (if known): __

Device Name: _ Butler Nucare® Root Conditioner with NovaMin®

INDICATIONS FOR USE:

Kein Mulig tax MSP

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K033295

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __X

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

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.