(9 days)
Not Found
No
The provided text describes a dental adhesive and its intended uses and performance studies. There is no mention of AI or ML technology in the device description, intended use, or performance summaries.
No.
The device is a one-component dental adhesive used for bonding dental restorative materials, not for treating a disease or condition therapeutically.
No
Explanation: The device is a dental adhesive used for bonding and sealing restorative materials to tooth structures. Its intended uses involve various dental restoration procedures, not the diagnosis of medical conditions.
No
The device description clearly states it is a "one-component dental adhesive," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "one-component dental adhesive" used for bonding dental materials to tooth structure and various restorative substrates. It is applied directly to the patient's teeth and restorations.
- Intended Use: The intended uses are all related to dental procedures performed directly on the patient's teeth and restorations, not on specimens taken from the body.
- Anatomical Site: The anatomical site is the "Tooth substance (dentin, enamel), root surface, cavities, tooth stumps," which are all parts of the patient's body, not specimens.
Therefore, this device falls under the category of a dental restorative material or dental adhesive, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
0
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.
1
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
2
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
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 GmbH
ESPE Platz
82229 Seefeld
Germany
Establishment Registration Number: 9611385 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruediger Franke
Regulatory Affairs Specialist
Phone: +49-8152-700 1802
Fax: +49-8152-700 1869
e-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
4
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 or
compomer filling materials | X | X
partly with Dual Cure
Activator |
| Root surface desensitization | X | X |
| Bonding of methacrylate-based fissure
sealants | X | X |
| Protective varnish for glass ionomer fillings | X | X |
5
| Indications Comparison | ADH19 | Scotchbond Universal
(K110302) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|-----------------------------------------|
| Repair of composite and compomer filling | × | × |
| Sealing of cavities prior to placement of
amalgam restorations | × | × |
| Cementation of indirect restorations in
combination with Suglue 3 for ADH19 or
Suglue 10 for Scotchbond Universal and
other resin cements (follow applicable
Instructions for Use) | × | ×
partly with Dual Cure
Activator |
| Bonding for all methacrylate-based light-,
self-, and dual-cure core build-up materials
and cements | × | ×
partly with Dual Cure
Activator |
| 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 reparation of tooth
stumps prior to temporary cementation of
indirect restorations | × | × |
| Intended Use
A material primarily intended to be used as
a bonding-promoting substance between
tooth substance and dental restorations. It
may also be used as a dentin sealant and
as a bonding agent for repair of
restorations. | × | × |
Table Comparison of indications
| Technology | ADH19 | Scotchbond Universal
(K110302) |
|----------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------------------|
| Vial for multiple dosing and the L-Pop
delivery device for unit dosed dispensing | X | X |
| One-component dental adhesive | X | X |
| Self-etch mode, selective enamel etch
mode or in a total-etch mode for both
direct and indirect dental restorative
procedures | X | X |
| Need to incorporate a separate ceramic
or metal primer | Not required | Not required |
| No separate Dual Cure Activator required
to bond self- or dual-cure composite and
cement 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
6
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 Docket | ||
| Number FDA-2013- | ||
| D-0350. CDRH | ||
| Document Number | ||
| 1811 | June 16, 2016 | Use of International Standard ISO 10993-1, Biological |
| evaluation of medical devices - Part 1: Evaluation and testing | ||
| within a risk management process - Guidance for Industry | ||
| and 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 reproductive |
| toxicity | ||
| 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 in |
| dentistry |
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.