(75 days)
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No
The document describes a chemical adhesive product and its performance, with no mention of AI or ML technology.
No
The device is a bonding agent used in dental restorative procedures, not to treat or prevent disease, but to enhance adhesion of restorative materials.
No
The device is a bonding agent used to enhance adhesion to dental tissue and metals during restorative procedures, not to diagnose a condition.
No
The device description clearly states it is a "light curing monomer mixture dissolved in acetone" and is a "one bottle adhesive," indicating it is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to bond resin composite restorative materials and compomers to dental hard tissue (enamel and dentin). This is a direct application to the patient's body for a restorative purpose.
- Device Description: The description details a chemical composition designed to interact with dental tissue for bonding. It's applied to the patient.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a disease, condition, or state of health. It's a therapeutic/restorative material.
- Anatomical Site: The anatomical site is dental hard tissue, which is part of the patient's body. IVDs typically analyze samples from the body (blood, urine, tissue, etc.).
IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
GLUMA ONE BOND is a light curing single component enamel/dentin adhesive for onoming of all current brands of resin composite restorative materials and compomers. It also enhances adhesion to metals such as amalgam. GLUMA ONE BOND combines primer and adhesive in single bottle.
Product codes
KLE
Device Description
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. The composition of GLUMA ONE BOND is based on three monomers: hydrophilic hydroxyethylmethacrylate (HEMA), 4-MET(A), and urethane di-methacrylate monomer. The organic solvent acetone acts as a carrier for the monomers and an effective water chaser.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Dental hard tissue (enamel and dentin)
Indicated Patient Age Range
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Intended User / Care Setting
Dental office
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A short-term clinical observation was done by eight dentists under regular office conditions, on some more than 300 restorations bonded with GLUMA ONE BOND. 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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Heraeus Kulzer, Inc. South Bend, IN. 46614 GLUMA ONE BOND 510(K)
KA74340
FEB 4 1998
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests movement or progression. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
N 1898 FEB
Ms. Cheryl V. Zimmerman Manager, Quality Operations & Regulatory Affairs Heraeus Kulzer, Incorporated Dental Prodcuts Division 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517
Re : K974390 Gluma One Bond Trade Name: Requlatory Class: II Product Code: KLE Dated: November 17, 1997 November 21, 1997 Received:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title_21, Parts_800_to_895 ... A ... ... ... ... ... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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: this 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffa.gov/cdrh/dsmamain.html".
Sincerely yours
Timoth A 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: GLUMA ONE BOND ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications For Use:
GLUMA ONE BOND is a light curing single component enamel/dentin adhesive for onoming of all current brands of resin composite restorative materials and compomers. It also enhances adhesion to metals such as amalgam. GLUMA ONE BOND combines primer and adhesive in single bottle.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Susan Runner | ||
| (Division Sign-Off) | ||
| Division of Dental, Infection Control, | ||
| and General Hospital Devices | ||
| 510(k) Number | K974390 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
(Optional Format 1-2-96)