GLUMA COMFORT BOND + DESENSITIZER by HERAEUS KULZER, INC.

Gluma Comfort Bond + Desensitizer is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also provides adhesion to metals such as amalgam. Gluma Comfort Bond + Desensitizer combines primer and adhesive in a single bottle.

Serves as a desensitizer/preventative in dentin hypersensitivity conditions by means of sealing exposed dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

Device Description

GLUMA COMFORT BOND + DESENSITIZER is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. It is an extension of the Gluma One Bond bonding system family. The product is a light curing monomer mixture dissolved in ethanol which, following conditioning with phosphoric acid, is applied to enamel and dentin prior to co- polymerization with the restorative. When compared with conventional bonding agents the main advantage of such simplified bond mediators is their reliability and ease of use in the dental office.

The composition of GLUMA COMFORT BOND + DESENSITIZER is based on three monomers which individually have been used in marketed dental products for decades. The hydrophilic hydroxyethylmethacrylate (HEMA) is essential for perfect wetting of and penetration into the conditioned tooth structure. Similarly, 4-MET(A) has hydrophilic and moieties for wetting and polymerization, whereas the urethane di-methacrylate monomer is responsible for formation of a cross-linked polymer network. The ethanol has the function of a carrier for the monomers while being an effective water chaser at the same time. The addition of glutaraldehyde to the Gluma One Bond formula allows the dental practitioner to obtain the complete desensitizing and other effects of Gluma Desensitizer and the bonding of Gluma One Bond all from one bottle. The combination of glutaraldehyde and HEMA in Gluma Desensitizer penetrates the dentinal tubules to a depth of 200um, setting up multiple walls that block the flow of fluids in the tubules. This immediately eliminates dentinal tubule-caused hypersensitivity. In addition, it has been found that glutaraldehyde bonds covalently to the collagen fibers, aiding re-wetting and resulting in reduced marginal contraction gap.

The application procedure is very easy. The solution is applied in small amounts to the conditioned moist tooth surface with two to three consecutive strokes, the water and ethanol is eliminated by a gentle air blast and finally, the resin is light cured for 20 seconds. Thorough in-vitro investigation has proven that the GLUMA COMFORT BOND + DESENSITIZER performs better than or at least as good as the leading resinous bonding systems available in the market. GLUMA COMFORT BOND + DESENSITIZER is also proven to bond to non-precious dental alloys, such as CoCr-based casting alloy and amalgam.

AI/ML Overview

This document describes a 510(k) submission for a dental adhesive and desensitizer, not an AI-powered medical device. Therefore, the information requested about acceptance criteria, study details (sample sizes, ground truth, experts, MRMC studies, standalone performance), and training sets, which are typically relevant for AI/ML device evaluations, cannot be provided based on the given text.

The document focuses on demonstrating the substantial equivalence of the GLUMA COMFORT BOND + DESENSITIZER to existing legally marketed predicate devices. The "study" mentioned is primarily an in-vitro investigation of its performance and cytotoxicity data.

Here's how the provided information relates to your request, where applicable:

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

The document does not explicitly state formal acceptance criteria in a quantitative table format as might be expected for an AI device. Instead, the performance is described qualitatively by comparing it to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Bonding Performance: Effective adhesion to dental hard tissue and various restorative materials.	"GLUMA COMFORT BOND + DESENSITIZER is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue." "Thorough in-vitro investigation has proven that the GLUMA COMFORT BOND + DESENSITIZER performs better than or at least as good as the leading resinous bonding systems available in the market." "GLUMA COMFORT BOND + DESENSITIZER is also proven to bond to non-precious dental alloys, such as CoCr-based casting alloy and amalgam."
Desensitizing Effect: Ability to reduce dentinal hypersensitivity.	"The addition of glutaraldehyde to the Gluma One Bond formula allows the dental practitioner to obtain the complete desensitizing and other effects of Gluma Desensitizer and the bonding of Gluma One Bond all from one bottle." "The combination of glutaraldehyde and HEMA in Gluma Desensitizer penetrates the dentinal tubules to a depth of 200um, setting up multiple walls that block the flow of fluids in the tubules. This immediately eliminates dentinal tubule-caused hypersensitivity."
Safety/Biocompatibility: Absence of unacceptable adverse effects.	"Based on this evidence and the cytotoxocity data, GLUMA COMFORT BOND + DESENSITIZER is recommended as an effective enamel/dentin adhesive when used in accordance with the instructions for use."
Ease of Use: Simplified application procedure.	"When compared with conventional bonding agents the main advantage of such simplified bond mediators is their reliability and ease of use in the dental office." "The application procedure is very easy."

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: Not specified. The document mentions "Thorough in-vitro investigation," but no specific sample sizes for tests (e.g., number of teeth, bonding interfaces) are provided.
Data Provenance: The document implies the investigations were conducted by the manufacturer, Heraeus Kulzer, Inc. The country of origin and whether the data was retrospective or prospective are not mentioned, though "in-vitro" strongly suggests a prospective, controlled laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the device is a chemical dental product, not an imaging or diagnostic device that requires expert interpretation for ground truth. Performance evaluations would likely involve standardized laboratory testing and measurements (e.g., bond strength, depth of penetration).

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

Not applicable for this type of device and its evaluation.

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 is not an AI-powered device, and no human reader studies are mentioned.

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

Not applicable as this is not an algorithm or AI device. The device's "standalone" performance refers to its physical and chemical properties and effectiveness on its own.

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

The "ground truth" for this device's performance would be established through objective laboratory measurements from the "in-vitro investigation." This would include:
- Bond Strength: Measured in megapascals (MPa) for adhesion effectiveness to enamel, dentin, and alloys.
- Penetration Depth: Measured in micrometers (µm) for the desensitizing agents into dentinal tubules.
- Cytotoxicity: Standardized tests to assess the toxicity to cells.
- Chemical Analysis: Verification of composition and stability.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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OCT 1 1999

Kaa2292

510(K) Summary

Date: June 30, 1999

Address: Heraeus Kulzer, Inc. 4315 S. Lafayette Blvd.
Contact: Cheryl V. Zimmerman 219-299-6662

GLUMA COMFORT BOND + Desensitizer Device:

Substantially Equivalent to:

Bond -1 (Jeneric/Penetron Incorporated, Wallingford, CT) ALL Bond 2 (BISCO) 3M Single Bond Dental Adhesive (3M) One Step Dental Adhesive

Device Description:

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practitioner to obtain the complete desensitizing and other effects of Gluma Desensitizer and the bonding of Gluma One Bond all from one bottle. The combination of glutaraldehyde and HEMA in Gluma Desensitizer penetrates the dentinal tubules to a depth of 200um, setting up multiple walls that block the flow of fluids in the tubules. This immediately eliminates dentinal tubule-caused hypersensitivity. In addition, it has been found that glutaraldehyde bonds covalently to the collagen fibers, aiding re-wetting and resulting in reduced marginal contraction gap.

Based on this evidence and the cytotoxocity data, GLUMA COMFORT BOND + DESENSITIZER is recommended as an effective enamel/dentin adhesive when used in accordance with the instructions for use.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1999

Ms. Cheryl V. Zimmerman Heraeus Kulzer, Incorporated Dental Products Division 4315 South Lafayette Boulevard 46614-2517 South Bend, Indiana

K992292 Re: GLUMA COMFORT BOND and Desensitizer Trade Name: Requlatory Class: II Product Code: KLE Dated: July 5, 1999 Received: July 7, 1999

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Ms. Zimmerman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if Known):

Device Name: Gluma Comfort Bond+ Desensitizer

Indications For Use:

Serves as a desensitizer/preventative in dentin hypersensitivity conditions by means of sealing exposed dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Suser Remoel

Division Sign-Off) Division of Dental, Infection Control and General Hospita 510(k) Number

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.