(447 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical composition of a dental adhesive, with no mention of AI or ML technologies.
No
The device is a dental adhesive used for binding materials to tooth structure, which is a restorative rather than therapeutic function.
No
Explanation: The device, Adhese Universal DC, is a dental adhesive used for restorative procedures, not for diagnosing medical conditions. Its intended use is to bond dental restorations.
No
The device description clearly states it is a dental adhesive, which is a physical material, not software. The performance studies also focus on physical properties like shear bond strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Missing tooth structure" and "Defective restorations," which are clinical conditions related to dental treatment.
- Device Description: The device is a dental adhesive used for bonding restorations to enamel and dentin. This is a material used directly in the mouth for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside the body to provide information about a physiological state, health, or disease. The performance studies focus on physical properties (shear bond strength) relevant to its function as a dental adhesive, not diagnostic accuracy.
IVDs are used to perform tests on samples taken from the body to diagnose or monitor medical conditions. This device is a therapeutic material used to restore tooth structure.
N/A
Intended Use / Indications for Use
- Missing tooth structure
- Defective restorations
Product codes (comma separated list FDA assigned to the subject device)
KLE, LBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Shear bond strength (Dentin) ≥20 MPa Self-curing
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Adhese Universal (K133318)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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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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
1
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
2
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 Affairs
Ivoclar Vivadent, Inc.
175 Pineview Drive
Amherst, New York 14228
716-264-2045
robert.streber@ivoclar.com |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | Ivoclar Vivadent, AG
Bendererstrasse 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: Adhese | ||||
| Universal (K133318) | Ivoclar Vivadent AG: Adhese | ||||
| Universal DC (K210804) | Yes | No | |||
| Indications for Use | - Direct-placed light-curing composite | ||||
| and compomer restorations. |
- Direct-placed core build-ups with light-
, self- and dual-curing composites. - Repairs of fractured composite and
compomer restorations.
– Adhesive cementation of indirect
restorations with light- and dual-curing
luting composites. - Sealing of prepared tooth surfaces
before temporary / permanent
cementation of indirect restorations. - Desensitization of hypersensitive
cervical areas. | - Missing tooth structure - Defective restorations | ☑ | | |
| Precaution
Measures/
Contraindications/
Processing
restrictions/ Side
effects | Contraindication - Do not use Adhese Universal if the
patient is known to be allergic to any of
the materials' ingredients or if the
stipulated working technique
cannot be employed. - Applications in which sufficient
illumination cannot be ensured (e.g.
cementation of root canal posts). - Direct pulp cappings. | Contraindications:
Do not use Adhese Universal DC if the
patient is known to be allergic to any of
the materials' ingredients or if the
stipulated working technique cannot be
employed.
Limitations for use: - Direct pulp capping
– Do not use Adhese Universal DC as a
primer for ceramic restorative materials.
A suitable ceramic primer
must be used (e.g. Monobond Etch &
Prime). | | ☑ | |
| Summary of
Indications,
Precaution
Measures/
Contraindications/
Processing
restrictions/
Side effects | In the Instructions for Use for the predicate Adhese Universal the application of the medical device
was assigned as "indications." According to the official definition of indications as clinical
conditions, the list of indications was updated in the IfU for Adhese Universal DC. The applications
are still part of the IfU under section "Description": Adhese Universal DC covers the same
application as Adhese Universal.
The contraindications are basically the same. | | | | |
| Working Principle | Adhese Universal is a light-curing
single-component dental adhesive for
enamel and dentin and is compatible
with all etching techniques (self-etch,
selective-enamel-etch and etch & rinse
techniques). | 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. | ☑ | | |
| Summary of
Working Principle | The main difference between Adhese Universal and Adhese Universal DC is that the new device is
dual curing in comparison to the predicate which can be cured with light only. | | | | |
| Delivery
forms/dosage | Bottle of liquid 5g
Vivapen 0.5 ml and 2 ml | Single Dose 0.1 g
Bottle 6 g with a separate brush | ☑ | ☐ | |
| Summary of
Delivery
forms/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 of
Storage Conditions | No difference. | | | | |
| Principles of
Operation | Step-by-step:
- Isolation
- Pulp protection/cavity liner
- Conditioning with phosphoric acid gel (optional)
- Handling VivaPen and bottle
- Application of the adhesive
- Light-curing the adhesive
- Application of the restorative or luting composite | Step-by-step application:
- Isolation
- Pulp protection/cavity liner
- Conditioning with phosphoric acid gel
- Activation of the Free Stand Single Dose
- Application of the Adhesive
- Curing the adhesive
- Application of the restorative or luting composite | ☑ | ☐ | |
| Summary
Principles of
operation | Basically, the step-by-step application is the same for both devices. | | | | |
| Chemical
Composition | Methacrylates, ethanol, water, highly
dispersed silicon dioxide, initiators and
stabilizers | HEMA, MDP, Bis-GMA, D3MA, ethanol,
methacrylate-modified polyacrylic
acid, silicon dioxide, potassium
hydroxide and camphorquinone. | ☑ | ☐ | |
| Summary of
Chemical
Composition | The chemical composition slightly differs between Adhese Universal and Adhese Universal DC, as
the new device is dual curing. 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. | | | | |
| Finished Device
Specification | EN 1641:2009- Dentistry – Medical
devices for dentistry – Materials
ISO 29022- Dentistry – Adhesive –
Notched-edge sheer bond strength test | EN 1641:2009- Dentistry – Medical
devices for dentistry – Materials
ISO 29022- Dentistry – Adhesive –
Notched-edge sheer bond strength test | ☐ | ☑ | |
| Summary of
Finished Device
Specification | No difference. | | | | |
| Sterilization | Not applicable. No sterilization
recommended. | Not applicable. No sterilization
recommended. | ☐ | ☑ | |
| Single use | Consumable material | Consumable material | ☐ | ☑ | |
| Performance-
Specification
Adhesion | Shear bond strength (Dentin): ≥25 MPa | Shear bond strength (Dentin) ≥20 MPa
Self-curing | ☑ | ☐ | |
| Summary of
Performance
Specification | 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. | | | | |
| Biocompatibility | These values are comparable to the specification of Adhese Universal.
evaluated for Biocompatibility according
to ISO 10993-1:2018, ISO 7405:2018
and ISO 14971:2012 | evaluated for Biocompatibility according
to ISO 10993-1:2018, ISO 7405:2018
and ISO 14971:2012 | ☐ | ☑ | |
| Discussion of
Biocompatibility | The results of the Biocompatibility Assessment for Adhese Universal DC is substantially
equivalent 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.