GLUMA COMFORT BOND

K992985 · Heraeus Kulzer, Inc. · KLE · Oct 14, 1999 · Dental

Device Facts

• Record ID: K992985
• Device Name: GLUMA COMFORT BOND
• Applicant: Heraeus Kulzer, Inc.
• Product Code: KLE · Dental
• Decision Date: Oct 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

GLUMA® Comfort Bond is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers, Polyglas®) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. GLUMA® Comfort Bond permits priming and bonding to be carried out in single step.

Device Story

Gluma Comfort Bond is a one-bottle, light-cured dental adhesive system. It functions as a priming and bonding agent for restorative dentistry. The device is applied by a clinician to conditioned, moist tooth surfaces using consecutive strokes, followed by air-drying and light curing for 20 seconds. It utilizes a chemical composition of HEMA for wetting/penetration, 4-META for bonding strength to composites and non-precious metal alloys (e.g., CoCr-based casting alloys, amalgam), and urethane di-methacrylate for cross-linked polymer network formation. Ethanol serves as a carrier and water-chaser. The device is used in a clinical setting to improve the retention of restorative materials to dental hard tissue.

Clinical Evidence

Bench testing only. Shear bond strength testing on dentin (25.1 ± 3.5 MPa) and enamel (30.8 ± 6.1 MPa). Gap-free sealing performance evaluated in laboratory settings. No clinical human trials presented.

Technological Characteristics

One-bottle, light-cured dental adhesive. Composition: HEMA (wetting/penetration), 4-META (bonding to composites/alloys), urethane di-methacrylate (cross-linking), and ethanol (solvent/carrier). Application: manual application to conditioned tooth surface, air-dry, 20-second light cure. Class II device.

Indications for Use

Indicated for use in restorative adhesive dentistry to bond resin-based filling materials (composites, compomers, Polyglas®) to hard dental tissues, and for bonding amalgam and laboratory-produced restorations.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Prime & Bond 2.1

Submission Summary (Full Text)

{0}------------------------------------------------

K992985

OCT 1 4 1999

## 510(K) Summary

Date: August 19, 1999

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

Gluma One Bond, available since October, 1998, has been proven to be an excellent, onebottle bonding system. In independent testing, Gluma One Bond had shear bond strength scores of 25.4 MPa to dentin and 35.1 MPa to enamel. In addition, all six fillings in the test were gap-free. The REALITY evaluation organization gave Gluma One Bond four stars, making it a REALITY'S Choice, calling it a "highly effective adhesive," due to its "proven ingredients." Their tests "found its bond strengths are quite comparable to Prime & Bond 2.1."2

Of particular interest in Gluma One Bond is 4-META. 4-META is a well known and proven chemical substance used in dentistry for many years. 4-META, besides adding to the strength of the bond to composites, also allows bonding to amalgam and other nonprecious metal alloys.

{1}------------------------------------------------

The acetone in the Gluma One Bond has been replaced with ethanol and the product name changed to Gluma Comfort Bond . Gluma Comfort Bonda is a one bottle adhesive, designed to bond resinous restarative matirlas to dental hard tissue. This product will provide the strength of 4-META and the ability to do a traditional 2-3 second drying after etching.

The composition of Gluma Comfort Bond 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.

An early shear bond strength test of Gluma Comfort Bond indicates scores of 25.1 ± 3.5 MPa to dentin and 30.8 ± 6.1 MPa to enamel. In addition, five of the six fillings in the test were gap-free.

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. GLUMA COMFORT BOND is also proven to bond to non-precious dental alloys, such as CoCr-based casting alloy and amalgam.

ﺍﻟﺨﻤﺮ ﺍﻟ

Testing method described in "Laboratory evaluation of one-component enamel/dentin bonding agents," Finger W.J., Fritz U., Am J Dent 1996; 9:206-210

² REALITY. Volume 13. Houston, TX: REALITY Publishing; 1999

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Ms. Cheryl V. Zimmerman Manager, Quality Operations & Regulatory Affairs Heraeus Kulzer, Inc. 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

K992985 Re : Gluma® Comfort Bond Trade Name: Requlatory Class: II Product Code: KLE Dated: September 2, 1999 Received: September 3, 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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

{3}------------------------------------------------

Page 2 - Ms. Zimmerman

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patrux Cincentiffer

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of

510(k) Number (if Known): 长99298S

Device Name: Gluma® Comfort Bond

Indications For Use:

GLUMA® Comfort Bond is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers, Polyglas®) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. GLUMA® Comfort Bond permits priming and bonding to be carried out in single step.

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

Concurrence of CDRH, Office of Device evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> |
|------------------------------------------|-------------------------------------------------------------------|
|------------------------------------------|-------------------------------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

| | (Optional Format 1-2-96) |
|--|--------------------------|
|--|--------------------------|

| (Division Sign-Off) | <div style="text-decoration:overline;">Susan Reang</div> |
|------------------------------------------------------------------------|----------------------------------------------------------|
| Division of Dental, Infection Control,<br>and General Hospital Devices | |
| 510(k) Number | <div style="text-decoration:overline;">Icandars</div> |