GLUMA ONE BOND

K990143 · Heraeus Kulzer, Inc. · KLE · Feb 25, 1999 · Dental

Device Facts

• Record ID: K990143
• Device Name: GLUMA ONE BOND
• Applicant: Heraeus Kulzer, Inc.
• Product Code: KLE · Dental
• Decision Date: Feb 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GLUMA ONE BOND is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. The product is a light curing monomer mixture dissolved in acetone which, following conditioning with phosphoric acid, is applied to enamel and dentin prior to co- polymerization with the restorative. Serves as a desensitizer/preventative in dentin hypersensitivity conditions by sealing demineralized dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

Device Story

GLUMA ONE BOND is a one-bottle, light-cured dental adhesive and desensitizer. It consists of a monomer mixture (HEMA, 4-MET(A), urethane di-methacrylate) in an acetone carrier. Used by dentists in clinical settings to bond restorative materials to enamel and dentin; also applied to treat dentin hypersensitivity. Procedure involves applying the solution to conditioned, moist tooth surfaces, removing the solvent via air blast, and light-curing for 20 seconds. The adhesive penetrates the tooth structure to form a cross-linked polymer network, sealing dentinal tubules to block fluid flow and reduce sensitivity. It also bonds to non-precious dental alloys and amalgam. The device simplifies bonding procedures, improving reliability and ease of use for the clinician.

Clinical Evidence

Short-term clinical observation conducted by eight dentists on over 300 restorations. Results confirmed ease of use, safety, and effectiveness. In-vitro investigation demonstrated performance equal to or better than leading resinous bonding systems.

Technological Characteristics

One-bottle light-curing adhesive. Composition: HEMA (hydrophilic monomer for wetting/penetration), 4-MET(A) (wetting/polymerization), urethane di-methacrylate (cross-linking), and acetone (solvent/carrier). Application: manual brush/stroke, air-dry, 20-second light cure. Compatible with enamel, dentin, non-precious dental alloys, and amalgam.

Indications for Use

Indicated for bonding resinous restorative materials to dental hard tissue (enamel and dentin) and as a desensitizer/preventative for dentin hypersensitivity by sealing demineralized dentinal tubules.

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.

Submission Summary (Full Text)

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eraeus Kulzer, Inc. South Bend, IN. 46614 GLUMA ONE BOND 510(K)

## Statement of Safety and Effectiveness

GLUMA ONE BOND is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. The product is a light curing monomer mixture dissolved in acetone 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 ONE 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 organic solvent acetone has the function of a carrier for the monomers while being an effective water chaser at the same time.

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 acetone 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 ONE BOND performs better than or at least as good as the leading resinous bonding systems available in the market. GLUMA ONE BOND is also proven to bond to non-precious dental alloys, such as CoCrbased casting alloy and amalgam.

The results of a short-term clinical observation done by eight dentists under regular office conditions, on some more than 300 restorations bonded with GLUMA ONE BOND confirms that the product is easy to use, safe, and effective. Based on this evidence and the very promising in vitro data, GLUMA ONE BOND is recommended as an effective enamel/dentin adhesive when used in accordance with the instructions for use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1999

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

Re: ' K990143 Gluma One Bond Trade Name: Regulatory Class: II Product Code: KLE । ਰੇ ਰੇ ਰੇ Dated: January 12, January 19, 1999 Received:

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to we have reviewed forferenced above and we have determined the market the device forly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholorstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment according in accordance with the devices chac nave 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 provisions of the ing 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 be babject to becting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: chis response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 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 Finding of Subbeancear Cycreaults in a classification for your mavice 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 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" (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 [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Heraeus Kulzer, Inc. South Bend, IN. 46614 GLUMA ONE BOND 510(K)

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K990143

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510(k) Number (if Known): K974,300 12974390

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Device Name: Gluma One Bond

Indications For Use:

Serves as a desensitizer/preventative in dentin hypersensitivity conditions by Serves as a decomorialized proventual 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)

Susan Runner

OR

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

Prescription Use
(Per 21 CFR 801.109)

· Over-The-Counter Use _

(Optional Format 1-2-96)