(41 days)
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.
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.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Gluma® Comfort Bond device:
The provided text is a 510(k) summary for the Gluma® Comfort Bond, which is a dental adhesive. It describes the device, its equivalence to other products, and presents some limited performance data.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as "acceptance criteria" in a formal table with pass/fail thresholds. Instead, the performance is presented through comparisons to a predecessor product (Gluma One Bond) and an independent evaluation organization (REALITY). The performance metrics provided are primarily shear bond strength and the number of gap-free fillings.
Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of showing "excellent" performance and comparability to established products:
| Acceptance Criteria (Inferred) | Reported Device Performance (Gluma Comfort Bond) |
|---|---|
| Shear Bond Strength to Dentin: Comparable to Gluma One Bond, or comparable to "highly effective adhesive" | 25.1 ± 3.5 MPa |
| Shear Bond Strength to Enamel: Comparable to Gluma One Bond | 30.8 ± 6.1 MPa |
| Gap-free Fillings: High percentage of gap-free fillings | 5 out of 6 fillings were gap-free |
| Bonding to non-precious dental alloys: Demonstrated capability | Proven to bond to non-precious alloys (CoCr-based casting alloy and amalgam) |
Study Information
Based on the provided text, the information about the studies is limited.
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the early shear bond strength test of Gluma Comfort Bond, the text states "five of the six fillings in the test were gap-free" and also provides bond strength results. This implies a very small sample size, likely 6 fillings for the gap-free assessment and potentially a similar small number of samples for the shear bond strength measurements (as results are presented as mean ± standard deviation, normally suggesting multiple measurements).
- Data Provenance: Not specified, but given the context of a 510(k) submission from a US-based company, it's likely the testing was done internally or by a US-based lab. The mention of "Am J Dent 1996" suggests a study published in an American journal, which might imply the testing method is recognized within the US and potentially internationally. The data appears to be prospective as it describes a specific test performed on the new Gluma Comfort Bond formulation.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The text does not provide any information about experts establishing ground truth for the shear bond strength or gap-free nature of the fillings. These are objective physical measurements, not typically requiring expert consensus for ground truth establishment.
- However, it does mention REALITY, an "independent testing" organization, giving Gluma One Bond four stars and calling it a "highly effective adhesive." The qualifications of REALITY's evaluators or the number of experts involved in their assessment are not detailed in this document.
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Adjudication Method for the Test Set:
- Not applicable as the evaluations are objective measurements (shear bond strength, gap-free assessment). There is no mention of subjective interpretation requiring adjudication.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI or diagnostic imaging devices where human readers interpret cases, and its purpose is to measure the impact of an AI tool on human performance. Gluma Comfort Bond is a dental adhesive, not an AI-powered diagnostic device.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the intrinsic physical properties of the adhesive itself.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the performance metrics (shear bond strength, gap-free fillings) are objective physical measurements obtained through standardized laboratory tests.
- For the bond to non-precious dental alloys, the "proven to bond" statement indicates qualitative experimental evidence.
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Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is not a machine learning or AI device.
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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.
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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
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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
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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 (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" (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.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
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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(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | ------------------------------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Optional Format 1-2-96) | |
|---|---|
| -- | -------------------------- |
| (Division Sign-Off) | Susan Reang |
|---|---|
| Division of Dental, Infection Control,and General Hospital Devices | |
| 510(k) Number | Icandars |
§ 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.