(9 days)
Direct Indications:
· Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
·Root surface desensitization
· Bonding of methacrylate-based fissure sealants
· Protective varnish for glass ionomer fillings
·Repair of composite and compomer fillings
· Sealing of cavities prior to placement of amalgam restorations
Indirect Indications:
· Cementation of indirect restoration with Suglue 3 and other resin cements (follow applicable Instructions for Use)
· Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements
· Cementation of veneers when combined with RelyX Veneer Cement
· Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
•Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
ADH19 is a one-component dental adhesive that is based on the chemistry of Scotchbond Universal (by 3M Deutschland GmbH, K110302, cleared as ADHESIVE EXL-759). It can be used in a self-etch mode, selective enamel etch mode or in a total-etch mode for both direct and indirect dental restorative procedures. It is intended to bond methacrylate-based restorative, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, alumina and zirconia). The primary use will be with lightcured materials, however it will have the capability to also bond self- or dual-cure composite and cement materials. In contrast to Scotchbond Universal, no separate Dual Cure Activator will be necessary in this case.
The provided text describes the 510(k) premarket notification for a dental adhesive named ADH19, comparing it to a predicate device, Scotchbond Universal.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" with specific numerical thresholds for performance. Instead, it describes a "substantial equivalence" claim based on comparisons to a predicate device. The primary performance metric mentioned throughout is shear bond strength.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ADH19) |
|---|---|---|
| Shear bond strength to enamel (self-etch & total-etch) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength to dentin (self-etch & total-etch) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength to various restoration materials (titanium, zirconia, NPM alloy, composite, high gold alloy, feldspathic glass ceramic, lithium disilicate) | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength with RelyX Ultimate to enamel and dentin | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Shear bond strength with different self-cure and dual-cure composites to enamel and dentin | Comparable to Scotchbond Universal | Comparable to Scotchbond Universal |
| Biocompatibility | Safe for its intended use, based on FDA guidance and international standards (e.g., ISO 10993 series) | Assessed by a board-certified toxicologist and concluded to be safe for its intended use. |
2. Sample size used for the test set and the data provenance
The document states that "In vitro testing was conducted to show the performance of ADH19 compared to the predicate device Scotchbond Universal regarding shear bond strength..." However, the sample size used for the test set is not specified. The data provenance is also not specified (e.g., country of origin, retrospective or prospective). It is an in vitro study, meaning it was conducted in a lab environment.
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 in the context of this submission. The "ground truth" for in vitro shear bond strength tests is the measured strength itself, not an expert assessment. For biocompatibility, a "board-certified toxicologist" assessed the product, but this isn't about establishing ground truth for individual test cases.
4. Adjudication method for the test set
This is not applicable as the study described is in vitro testing of physical properties, not a clinical study involving human assessment that would require 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
There is no mention of an MRMC comparative effectiveness study or any AI component in this device submission. This is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a dental adhesive, not an algorithm.
7. The type of ground truth used
For the shear bond strength tests, the "ground truth" is the measured physical property (shear bond strength) obtained through standardized in vitro testing methods (e.g., ISO 29022: 2013).
For biocompatibility, the "ground truth" is established through assessment against recognized international standards (ISO 10993 series) and FDA guidance, with the conclusion made by a board-certified toxicologist.
8. The sample size for the training set
This is not applicable. The device is a dental adhesive, not an algorithm or AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 31, 2019
3M Deutschland GmbH % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K192961
Trade/Device Name: Adh19 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE Dated: October 21, 2019 Received: October 22, 2019
Dear Prithul Bom:
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.
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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 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.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192961
Device Name ADH19
Indications for Use (Describe)
Direct Indications:
· Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
·Root surface desensitization
· Bonding of methacrylate-based fissure sealants
· Protective varnish for glass ionomer fillings
·Repair of composite and compomer fillings
· Sealing of cavities prior to placement of amalgam restorations
Indirect Indications:
· Cementation of indirect restoration with Suglue 3 and other resin cements (follow applicable Instructions for Use)
· Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements
· Cementation of veneers when combined with RelyX Veneer Cement
· Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
•Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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3M Deutschland GmbH
Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
Tel.:+49 (0)8152 700-0 Fax+49 (0)8152 700-1366 Internet: www.3MESPE.de E-Mail: info3MESPE@3M.com WEEE-Req.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary
| Submitter: | 3M Deutschland GmbHESPE Platz82229 SeefeldGermanyEstablishment Registration Number: 9611385 |
|---|---|
| Contact Person | Ruediger FrankeRegulatory Affairs SpecialistPhone: +49-8152-700 1802Fax: +49-8152-700 1869e-mail: ruediger.franke@3M.com |
| Date: | August 21, 2019 |
| Trade Name: | ADH19 |
| Common Name: | Adhesive |
| Classification Name: | Resin Tooth Bonding Agent(21 CFR 872.3200, product code KLE) |
| Device Class: | Class II |
Predicate Devices ................................... Scotchbond Universal (K110302)
Description of Device
ADH19 is a one-component dental adhesive that is based on the chemistry of Scotchbond Universal (by 3M Deutschland GmbH, K110302, cleared as ADHESIVE EXL-759). It can be used in a self-etch mode, selective enamel etch mode or in a total-etch mode for both direct and indirect dental restorative procedures. It is intended to bond methacrylate-based restorative, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, alumina and zirconia). The primary use will be with lightcured materials, however it will have the capability to also bond self- or dual-cure composite and cement materials. In contrast to Scotchbond Universal, no separate Dual Cure Activator will be necessary in this case.
Sitz: 41453 Neuss · Handelsregister: B 1878 Amtsgericht Neuss Geschäftsführer: Christiane Grün, Manfred Hinz, Oliver Leick Vorsitzende der Geschäftsführung: Christiane Grün: Vorsitzender des Aufsichtsrates: Günter Gressler
Image /page/3/Picture/11 description: The image is a logo for "Deutsche Dental Industrie". The logo consists of a stylized letter "G" inside of three concentric circles. To the right of the circles is the text "Deutsche Dental Industrie" stacked vertically.
3M Deutschland GmbH
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Applicable Standards for Product Tests
- . ISO 29022: 2013: Dentistry - Adhesive - Notched-edge sheer bond strength test
Indications for ADH19
Direct Indications:
- Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials
- Root surface desensitization .
- . Bonding of methacrylate-based fissure sealants
- . Protective varnish for glass ionomer fillings
- Repair of composite and compomer fillings .
- Sealing of cavities prior to placement of amalgam restorations .
Indirect Indications:
- Cementation of indirect restorations in combination with Suglue 3 and other resin cements . (follow applicable Instructions for Use)
- Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and . cements
- . Cementation of veneers when combined with RelyX Veneer Cement
- . Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
- Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations
Comparison
ADH19 was compared to Scotchbond Universal regarding indications for use, intended use, composition, technology and physical and mechanical properties. The tables below summarize the indications and technology of ADH19 and predicate devices:
| Indications Comparison | ADH19 | Scotchbond Universal(K110302) |
|---|---|---|
| Indications for Use(from the labeling) | ||
| Bonding for all methacrylate-based light-,dual-, and self-cure composite orcompomer filling materials | X | Xpartly with Dual CureActivator |
| Root surface desensitization | X | X |
| Bonding of methacrylate-based fissuresealants | X | X |
| Protective varnish for glass ionomer fillings | X | X |
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| Indications Comparison | ADH19 | Scotchbond Universal(K110302) |
|---|---|---|
| Repair of composite and compomer filling | × | × |
| Sealing of cavities prior to placement ofamalgam restorations | × | × |
| Cementation of indirect restorations incombination with Suglue 3 for ADH19 orSuglue 10 for Scotchbond Universal andother resin cements (follow applicableInstructions for Use) | × | ×partly with Dual CureActivator |
| Bonding for all methacrylate-based light-,self-, and dual-cure core build-up materialsand cements | × | ×partly with Dual CureActivator |
| Cementation of veneers when combinedwith RelyX Veneer Cement | × | × |
| Intraoral repair of composite restorations,porcelain fused to metal, and all-ceramicrestorations without extra primer | × | × |
| Sealing of cavities and reparation of toothstumps prior to temporary cementation ofindirect restorations | × | × |
| Intended UseA material primarily intended to be used asa bonding-promoting substance betweentooth substance and dental restorations. Itmay also be used as a dentin sealant andas a bonding agent for repair ofrestorations. | × | × |
Table Comparison of indications
| Technology | ADH19 | Scotchbond Universal(K110302) |
|---|---|---|
| Vial for multiple dosing and the L-Popdelivery device for unit dosed dispensing | X | X |
| One-component dental adhesive | X | X |
| Self-etch mode, selective enamel etchmode or in a total-etch mode for bothdirect and indirect dental restorativeprocedures | X | X |
| Need to incorporate a separate ceramicor metal primer | Not required | Not required |
| No separate Dual Cure Activator requiredto bond self- or dual-cure composite andcement materials | Not required | Required |
Table Comparison to Predicate Technology
ADH19 and Scotchbond Universal are dental adhesive materials containing monomers, fillers, solvents, initiators, silanization agents and stabilizers. 3M Deutschland GmbH is providing
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information to the Agency regarding information to FDA about the composition of ADH19 and compared this to the predicate device.
In vitro testing was conducted to show the performance of ADH19 compared to the predicate device Scotchbond Universal regarding shear bond strength to enamel (self-etch & total-etch), to dentin (self-etch & total-etch), to restoration materials titanium, zirconia, NPM alloy, composite, high gold alloy, feldspathic glass ceramic, lithium disilicate, with RelyX Ultimate to enamel and dentin, and with different self cure and dual cure composites to enamel and dentin. The results of ADH19 are comparable to Scotchbond Universal. In summary, 3M Deutschland GmbH concludes that ADH19 is substantially equivalent to the predicate devices regarding performance and physical and mechanical properties.
Biocompatibility
The biocompatibility assessment for the products was conducted in accordance with the following guidance:
| Guidance | Edition | Title |
|---|---|---|
| US FDA DocketNumber FDA-2013-D-0350. CDRHDocument Number1811 | June 16, 2016 | Use of International Standard ISO 10993-1, Biologicalevaluation of medical devices - Part 1: Evaluation and testingwithin a risk management process - Guidance for Industryand Food and Drug Administration Staff |
| ISO 10993-1 | 2018 | Evaluation and testing within a risk management process |
| ISO 10993-3 | 2014 | Tests for genotoxicity, carcinogenicity and reproductivetoxicity |
| ISO 10993-5 | 2009 | Tests for in vitro cytotoxicity |
| ISO 10993-6 | 2016 | Tests for local effects after implantation |
| ISO 10993-10 | 2010 | Tests for irritation and skin sensitization |
| ISO 10993-11 | 2017 | Tests for systemic toxicity |
| ISO 10993-12 | 2012 | Sample preparation and reference materials |
| ISO 10993-18 | 2005 | Chemical characterization of materials |
| ISO/TR 10993-22 | 2017 | Guidance on nanomaterials |
| ISO 7405 | 2018 | Evaluation of biocompatibility of medical devices used indentistry |
Table Guidances for biocompatibility assessment
The biocompatibility of ADH19 has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is ADH19 is safe for its intended use.
Conclusion
Comparisons of the indications for use/intended use, composition, technology, and physical and mechanical properties showed that ADH19 does not raise any new questions about safety and effectiveness and 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.