(67 days)
Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites
Monobond Etch & Prime is used to condition silica-based ceramic surfaces for the adhesive bond with luting composites from the Variolink or Multilink product lines, for example, Monobond Etch & Prime etches and silanizes silicate ceramic suffaces in one working step. The new product combines the role of bonding agent with that of etchant. Typically the dental technician would etch the ceramic with 5% hydrofluoric acid but this step is achieved using Monobond Etch & Prime. The etching step was carried out outside the mouth and the new product is also limited to extra-oral applications of the new product are limited to silica ceramics, Oxide ceramics, metal, composite and fibre-reinforced composites are not indicated. This is because only silica glass ceramics required etching with hydrofluoric acid and therefore the benefit of using Monobond Etch & Prime is primarily relevant for this group of materials.
This document is a 510(k) premarket notification for a dental device, specifically a resin tooth bonding agent called Monobond® Etch & Prime (K150164). The document primarily focuses on establishing substantial equivalence to a predicate device, Monobond Plus (K090826), rather than providing detailed acceptance criteria and a comprehensive study report for the proposed device itself.
Based on the provided text, the information requested cannot be fully extracted for the new device, Monobond® Etch & Prime, because the document is a regulatory submission for substantial equivalence, not a detailed clinical study report with specific performance metrics defined as acceptance criteria.
However, I can extract the available information and highlight what is missing.
Here's an attempt to answer your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Monobond® Etch & Prime) |
|---|---|
| Tensile Bond Strength to Glass Ceramics | Conforms to specification and substantially equivalent to predicate device. |
| Biocompatibility | Assessed through testing according to EN ISO 10993-1:2009 and EN ISO 7405:2008. (Specific results not given) |
Note on Acceptance Criteria: The document states, "As no product specific standard exists for the subject device," indicating that formal, externally defined acceptance criteria for the new device were not applied verbatim. Instead, the performance was compared to its own internal specification and to the predicate device for substantial equivalence. "Conforming to the specification" implies internal acceptance criteria were met, but the specific numerical values are not provided.
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 "tests for Monobond Etch & Prime and Monobond Plus tensile bond strength" but does not provide details on the number of samples or specimens tested.
- Data Provenance: Not specified. The country of origin of the data is not mentioned, nor is it stated whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided as this is not a study involving expert assessment or ground truth establishment in a clinical context. The testing described is laboratory-based physical and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as this is not a study involving human interpretation of data requiring adjudication.
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
This information is not applicable/not provided. The device is a dental bonding agent, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical product (a chemical agent), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the tensile bond strength testing, the "ground truth" would be the physically measured bond strength under controlled laboratory conditions, not expert consensus, pathology, or outcomes data. For biocompatibility, the ground truth would be the results of standardized biological assays per EN ISO 10993-1:2009 and EN ISO 7405:2008.
8. The sample size for the training set
This information is not applicable/not provided. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, no training set for an algorithm is involved.
Summary of what can be gleaned from the document:
The primary "study" mentioned for Monobond® Etch & Prime is laboratory testing for tensile bond strength and biocompatibility. The purpose of these tests was to demonstrate substantial equivalence to the predicate device, Monobond Plus (K090826).
- Tensile bond strength on glass ceramics was tested and found to conform to specification and be "substantially equivalent" to the predicate. The methods for the new device were tensile bond strength, while the predicate historically used shear bond strength, making direct comparison difficult, but a specific comparison was still made for tensile bond strength to show equivalence.
- Biocompatibility was assessed according to EN ISO 10993-1:2009 and EN ISO 7405:2008.
The document is a regulatory submission for a Class II medical device, and as such, it emphasizes comparison to a predicate device and adherence to regulatory standards rather than presenting detailed clinical trial data or comprehensive study results with explicit, quantifiable acceptance criteria and multi-reader analyses typical for diagnostic AI devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2015
Ivoclar Vivadent, Inc. Ms. Donna Marie Hartnett, Esq. Director, QA/Regulatory Affairs 175 Pineview Drive Amherst, NY 14228
Re: K150164
Trade/Device Name: Monobond® Etch & Prime Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: January 21, 2015 Received: January 26, 2015
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Donna Marie Hartnett
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tina
Kiang-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150164
Device Name MONOBOND ETCH & PRIME
Indications for Use (Describe) Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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| Contact: | Donna Marie Hartnett |
|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, SchaanFL-9494, Liechtenstein+423-235-3535 |
| Date Prepared: | February 10, 2015 |
| Proprietary Name: | Monobond® Etch & Prime |
| Classification Name: | Agent, Tooth bonding, Resin (872.3200)(Classification Code KLE) |
| Predicate Device: | Monobond Plus (K090826) |
Device Description: Monobond Etch & Prime is used to condition silica-based ceramic surfaces for the adhesive bond with luting composites from the Variolink or Multilink product lines, for example, Monobond Etch & Prime etches and silanizes silicate ceramic suffaces in one working step. The new product combines the role of bonding agent with that of etchant. Typically the dental technician would etch the ceramic with 5% hydrofluoric acid but this step is achieved using Monobond Etch & Prime. The etching step was carried out outside the mouth and the new product is also limited to extra-oral applications of the new product are limited to silica ceramics, Oxide ceramics, metal, composite and fibre-reinforced composites are not indicated. This is because only silica glass ceramics required etching with hydrofluoric acid and therefore the benefit of using Monobond Etch & Prime is primarily relevant for this group of materials.
Intended Use:
Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites
Comparison to Predicate: The predicate device to which Monobond Etch & Prime has been compared is Monobond Plus (K090826). For this application, Monobond Etch & Prime has been compared to its predicate with regard to chemical composition, physical properties, and indications for use. The comparison shows that Monobond Etch & Prime is substantially equivalent to the predicate device.
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510(K) SUMMARY (rev 2.10.15) Monobond® Etch & Prime
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| Predicate - Monobond Plus (K090826) | Subject Device |
|---|---|
| Bonding agent between luting composites and glass/oxide ceramic, metal, composite and fiber-reinforced composite restorations. | Conditioning of silica-based ceramic surfaces for the adhesive bond with luting composites. |
| Monobond Plus is a dilute solution of adhesive monomers and silane which enable it to be used with various substrates. | Monobond Etch & Prime is a dilute solution of silane, a ceramic etching agent and an adhesive monomer, and can be used only with silica ceramics |
| Tensile bond strength to glass ceramics was tested for comparison purposes to the subject device. | Tensile bond strength testing showed that the performance of the subject device is conforming to the specification and substantially equivalent to the predicate device. |
Technological Characteristics and Testing Summary: As no product specific standard exists for the subject device, testing was conducted under ISO 1641:2009 Dentistry - Medical Devices for dentistry - Materials.
The device was tested for Tensile bond strength. The predicate referred to shear bond strength. The methods and specifications cannot be directly compared. However, tests for Monobond Etch & Prime and Monobond Plus tensile bond strength showed that the performance of the new product is conforming to the specification and substantially equivalent to the predicate. Only the bond strength to glass ceramics is considered as use with oxide ceramics is not indicated for Monobond Etch & Prime. The key function of Monobond Etch & Prime is to silanise silica glass ceramics. This is achieved using exactly the same silane agent as used in Monobond Plus. Although the compositions are different, the subject device has been assessed for biocompatibility through testing according EN ISO 10993-1:2009 and EN ISO 7405:2008.
The device design, i.e. delivery form, and the predicate device are the same. They are both applied extra-orally. The Intended use of the subject and the predicate device are the same except that the subject device is limited for use with silica-based ceramic surfaces. This be because only silica glass ceramics require etching with hydrofluoric acid and therefore the benefit of using the subject device is relevant for this group of materials.
CONCLUSION: The above data and analysis demonstrates that Monobond Etch & Prime is substantially equivalent to the predicate device.
§ 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.