(447 days)
- Missing tooth structure
- Defective restorations
Adhese Universal DC is a dual-curing, single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective enamel etch, etch & rinse techniques). The areas of application include adhesive cementation of indirect restorations and direct restorative procedures. Adhese Universal DC is available in Free Stand Single Dose units. The applicator is coated with co-initiators required for the self-curing reaction. The initiator and adhesive are mixed together by dipping the applicator into the single dose unit containing the liquid Adhese Universal DC.
The report describes "Adhese Universal DC," a dual-curing dental adhesive. It uses the "Adhese Universal" (K133318) as its predicate device. The information provided heavily focuses on the comparison between the proposed device and the predicate device, especially regarding their working principles, chemical composition, and performance specifications.
Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate: Adhese Universal) | Reported Device Performance (Adhese Universal DC) |
|---|---|
| Shear bond strength (Dentin): ≥25 MPa | Shear bond strength (Dentin): ≥20 MPa (Self-curing) |
Deviation Summary: The proposed device, Adhese Universal DC, has a lower acceptance criterion for shear bond strength (Dentin) at ≥20 MPa compared to the predicate's ≥25 MPa. This is explicitly noted in the document, attributing the lower value to the self-curing mode of Adhese Universal DC, which generally exhibits lower values.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing was performed to test the physical property (shear bond strength)." However, it does not provide any specific sample sizes for this testing.
Regarding data provenance, the document does not specify the country of origin of the data. It indicates the testing was "Bench testing," implying laboratory-based testing, but does not clarify if it was retrospective or prospective in data collection approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided as the "test set" and "ground truth" concepts as typically applied to AI/software validation studies (with human experts evaluating outputs) are not relevant here. This is a material science study focused on physical properties, not diagnostic accuracy requiring expert consensus.
4. Adjudication Method for the Test Set
This is not applicable as the study is a bench test measuring physical properties, not a clinical trial or diagnostic accuracy study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This is not applicable. An MRMC study is relevant for assessing human reader performance in conjunction with AI. This document describes the performance of a dental adhesive, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a dental adhesive, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measured physical property of "Shear bond strength (Dentin)" obtained through laboratory bench testing according to established standards. It's an objective measurement rather than expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic studies.
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" relates to machine learning models. This document describes a physical product, not a software algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
Summary of the Study and How it Proves Acceptance Criteria:
The study proving the device meets its acceptance criteria is a non-clinical performance bench test. Specifically, it involved measuring the shear bond strength (Dentin) of the Adhese Universal DC in its self-curing mode.
The acceptance criterion for Adhese Universal DC's shear bond strength (Dentin) in self-curing mode was set at ≥20 MPa. While the document states that "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode," it does not explicitly report the obtained value from the bench testing for Adhese Universal DC. It only states the specification. To definitively prove the device meets the acceptance criteria, the actual measured performance data of Adhese Universal DC on shear bond strength would need to be compared against the ≥20 MPa criterion. The document implies compliance through the "Summary of Performance Specification" which states, "The specification for Adhese Universal DC describes lower values (20 MPa) for shear bond strength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode of Adhese Universal DC which generally shows lower values." This statement argues for the reason for the lower criterion but doesn't report the achieved value against that criterion.
The study also included Biocompatibility testing according to ISO 10993-1:2018, ISO 7405:2018, and ISO 14971:2012. The conclusion from this testing was that "The results of the Biocompatibility Assessment for Adhese Universal DC is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Adhese Universal." This demonstrates the device meets biocompatibility safety criteria by showing equivalence to a legally marketed predicate.
In essence, the study framework described is a comparative non-clinical bench study focusing on physical properties and biocompatibility to establish substantial equivalence to a predicate device for regulatory clearance.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2022
Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent, Inc 175 Pineview Drive Amherst. New York 14228
Re: K210804
Trade/Device Name: Adhese Universal DC, Cention Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE, LBH Dated: March 5, 2022 Received: March 10, 2021
Dear Lori Aleshin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210804
Device Name Adhese® Universal DC
Indications for Use (Describe)
-
Missing tooth structure
-
Defective restorations
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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Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" underneath. The logo also includes a series of green and blue dots above and to the right of the company name. The logo is simple and modern, and it conveys a sense of innovation and professionalism.
Adhese Universal DC- K210804
| Contact: | Robert Streber, Director of Quality & Regulatory AffairsIvoclar Vivadent, Inc.175 Pineview DriveAmherst, New York 14228716-264-2045robert.streber@ivoclar.com |
|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535 |
| Date Prepared: | May 5, 2022 |
| Proprietary Name: | Adhese® Universal DC (K210804) |
| Primary Classification Name: | Agent, Tooth Bonding, Resin (872.3200)(Classification Code KLE) |
| Secondary Classification Name: | Varnish, Cavity (872.3260)(Classification Code LBH) |
| Predicate Device: | Adhese Universal (K133318) by Ivoclar Vivadent, AG |
Device Description: Adhese Universal DC is a dual-curing, single-component dental adhesive for enamel and dentin that is compatible with all etching techniques (self-etch, selective enamel etch, etch & rinse techniques). The areas of application include adhesive cementation of indirect restorations and direct restorative procedures. Adhese Universal DC is available in Free Stand Single Dose units. The applicator is coated with co-initiators required for the self-curing reaction. The initiator and adhesive are mixed together by dipping the applicator into the single dose unit containing the liquid Adhese Universal DC.
Indications for Use:
- Missing tooth structure -
- -Defective restorations
Comparison to Predicate: The primary predicate device to which Adhese Universal DC has been compared is Ivoclar Vivadent, AG Adhese Universal (K133318).
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Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" underneath. Above the company name are a series of green and blue dots and squares. To the right of the logo is the number 2.
| Predicate Device: | Proposed Device: | Deviation | |||
|---|---|---|---|---|---|
| Device | Ivoclar Vivadent AG: AdheseUniversal (K133318) | Ivoclar Vivadent AG: AdheseUniversal DC (K210804) | Yes | No | |
| Indications for Use | - Direct-placed light-curing compositeand compomer restorations.- Direct-placed core build-ups with light-, self- and dual-curing composites.- Repairs of fractured composite andcompomer restorations.– Adhesive cementation of indirectrestorations with light- and dual-curingluting composites.- Sealing of prepared tooth surfacesbefore temporary / permanentcementation of indirect restorations.- Desensitization of hypersensitivecervical areas. | - Missing tooth structure- Defective restorations | ☑ | ||
| PrecautionMeasures/Contraindications/Processingrestrictions/ Sideeffects | Contraindication- Do not use Adhese Universal if thepatient is known to be allergic to any ofthe materials' ingredients or if thestipulated working techniquecannot be employed.- Applications in which sufficientillumination cannot be ensured (e.g.cementation of root canal posts).- Direct pulp cappings. | Contraindications:Do not use Adhese Universal DC if thepatient is known to be allergic to any ofthe materials' ingredients or if thestipulated working technique cannot beemployed.Limitations for use:- Direct pulp capping– Do not use Adhese Universal DC as aprimer for ceramic restorative materials.A suitable ceramic primermust be used (e.g. Monobond Etch &Prime). | ☑ | ||
| Summary ofIndications,PrecautionMeasures/Contraindications/Processingrestrictions/Side effects | In the Instructions for Use for the predicate Adhese Universal the application of the medical devicewas assigned as "indications." According to the official definition of indications as clinicalconditions, the list of indications was updated in the IfU for Adhese Universal DC. The applicationsare still part of the IfU under section "Description": Adhese Universal DC covers the sameapplication as Adhese Universal.The contraindications are basically the same. | ||||
| Working Principle | Adhese Universal is a light-curingsingle-component dental adhesive forenamel and dentin and is compatiblewith all etching techniques (self-etch,selective-enamel-etch and etch & rinsetechniques). | Adhese Universal DC is a dual-curing,single-component dental adhesive forenamel and dentin that is compatiblewith all etching techniques (self-etch,selective enamel-etch, etch & rinsetechniques).The areas of application includeadhesive cementation of indirectrestorations and direct restorativeprocedures.Adhese Universal DC is available inFree Stand Single Dose units. Theapplicator is coated with co-initiatorsrequired for the self-curing reaction. Theinitiator and adhesive are mixedtogether by dippingthe applicator into the single dose unitcontaining the liquid Adhese UniversalDC. | ☑ | ||
| Summary ofWorking Principle | The main difference between Adhese Universal and Adhese Universal DC is that the new device isdual curing in comparison to the predicate which can be cured with light only. | ||||
| Deliveryforms/dosage | Bottle of liquid 5gVivapen 0.5 ml and 2 ml | Single Dose 0.1 gBottle 6 g with a separate brush | ☑ | ☐ | |
| Summary ofDeliveryforms/dosage | Single doses and bottle available; difference in the amount only; | ||||
| Storage Conditions | 24 months at 2-28 °C / 36-82 °F | 24 months at 2-28 °C / 36-82 °F | ☐ | ☑ | |
| Summary ofStorage Conditions | No difference. | ||||
| Principles ofOperation | Step-by-step:1. Isolation2. Pulp protection/cavity liner3. Conditioning with phosphoric acid gel (optional)4. Handling VivaPen and bottle5. Application of the adhesive6. Light-curing the adhesive7. Application of the restorative or luting composite | Step-by-step application:1. Isolation2. Pulp protection/cavity liner3. Conditioning with phosphoric acid gel4. Activation of the Free Stand Single Dose5. Application of the Adhesive6. Curing the adhesive7. Application of the restorative or luting composite | ☑ | ☐ | |
| SummaryPrinciples ofoperation | Basically, the step-by-step application is the same for both devices. | ||||
| ChemicalComposition | Methacrylates, ethanol, water, highlydispersed silicon dioxide, initiators andstabilizers | HEMA, MDP, Bis-GMA, D3MA, ethanol,methacrylate-modified polyacrylicacid, silicon dioxide, potassiumhydroxide and camphorquinone. | ☑ | ☐ | |
| Summary ofChemicalComposition | The chemical composition slightly differs between Adhese Universal and Adhese Universal DC, asthe new device is dual curing. The results of the Biocompatibility Assessment for Adhese UniversalDC is substantially equivalent to the results of the Biocompatibility Assessment for the predicatedevice Adhese Universal. | ||||
| Finished DeviceSpecification | EN 1641:2009- Dentistry – Medicaldevices for dentistry – MaterialsISO 29022- Dentistry – Adhesive –Notched-edge sheer bond strength test | EN 1641:2009- Dentistry – Medicaldevices for dentistry – MaterialsISO 29022- Dentistry – Adhesive –Notched-edge sheer bond strength test | ☐ | ☑ | |
| Summary ofFinished DeviceSpecification | No difference. | ||||
| Sterilization | Not applicable. No sterilizationrecommended. | Not applicable. No sterilizationrecommended. | ☐ | ☑ | |
| Single use | Consumable material | Consumable material | ☐ | ☑ | |
| Performance-SpecificationAdhesion | Shear bond strength (Dentin): ≥25 MPa | Shear bond strength (Dentin) ≥20 MPaSelf-curing | ☑ | ☐ | |
| Summary ofPerformanceSpecification | The specification for Adhese Universal DC describes lower values (20 MPa) for shear bondstrength (dentin) compared to Adhese Universal (25 MPa) due to the self-curing mode of AdheseUniversal DC which generally shows lower values. | ||||
| Biocompatibility | These values are comparable to the specification of Adhese Universal.evaluated for Biocompatibility accordingto ISO 10993-1:2018, ISO 7405:2018and ISO 14971:2012 | evaluated for Biocompatibility accordingto ISO 10993-1:2018, ISO 7405:2018and ISO 14971:2012 | ☐ | ☑ | |
| Discussion ofBiocompatibility | The results of the Biocompatibility Assessment for Adhese Universal DC is substantiallyequivalent to the results of the Biocompatibility Assessment for the predicate device |
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Image /page/5/Picture/1 description: The image shows the Ivoclar Vivadent logo. The logo is blue and green, and it features the company name in a stylized font. There are green and blue dots above the company name. There is a small number 3 on the right side of the logo.
on
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Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is blue and green, with the words "ivoclar vivadent" in a stylized font. Below the company name is the slogan "passion vision innovation" in a smaller font. To the right of the company name is the number 4.
Substantial Equivalence to the predicate:
Adhese Universal and Adhese Universal DC are both dental adhesives. The main difference between the two devices is that Adhese Universal is light-curing compared to Adhese Universal DC which is dual-curing. Therefore, Adhese Universal DC is substantially equivalent to the predicate device, Adhese Universal.
Differences:
The main difference between Adhese Universal and Adhese Universal DC is that the new device is dual-curing compared to the light-curing Adhese Universal. As the new device is dual-curing the chemical composition has been slightly adapted for Adhese Universal DC.
Non-clinical performance testing:
Bench testing was performed to test the physical property (shear bond strength) included in the Finished Device Specification for the subject device according to EN ISO 1641:2009 -Dentistry- Medical devices for dentistry - Materials and ISO 29022- Dentistry - Adhesive -Notched-edge sheer bond strength test.
Biocompatibility:
The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2018, ISO 7405:2018 and ISO 14971:2012. Uncured Adhese Universal as well as extracts of polymerized Adhese Universal DC possess a cytotoxic potential in the XTT assay. The clinical experience with a previous generation of the product (Adhese Universal) indicates no adverse effect in clinical use. The product, particularly in the uncured state may cause sensitization against methacrylates. This is typical for all resin-based dental materials. On the basis of the clinical experience with a previous generation of the product it can be concluded that the products do not cause oral mucosal or gingival irritation. There is no material mediated pyrogenicity. According to the information available, the product have no acute nor subacute system toxicity. Subchronic or chronic toxicity is not expected. According to the data available Adhese Universal DC is not genotoxic nor carcinogenic. According to the current knowledge, it can be concluded that Adhese Universal DC does not cause adverse reactions upon implantation in teeth. Adhese Universal DC are expected not to cause pulp or dentine damage. There is no indication that toxic degradation products might be released during body contact.
On the basis of the toxicological evaluation of the product and the longstanding worldwide clinical use of similar materials it can be concluded that the benefits provided by the final product will exceed any potential risks produced by device materials providing that the instructions for use have been followed. The results of the Biocompatibility Assessment for Adhese Universal DC is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Adhese Universal.
Conclusion:
Adhese Universal and Adhese Universal DC are both dental adhesives. The main difference between the two devices is that Adhese Universal is light-curing compared to Adhese Universal DC which is dual-curing. The indications / contraindications are basically the same. The device performance is substantially equivalent. The biocompatibility and storage stability of the new formulation was fully assessed and is substantially equivalent to Adhese Universal.
Therefore, Adhese Universal DC is substantially equivalent to the predicate device, Adhese Universal.
§ 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.