(106 days)
- All classes of fillings (according to Black) with light-curing composite or compomer . filling materials
- Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of . composite, compomer, ceramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE
- Cementation of veneers when combined with RelyX Veneer Cement, manufactured . by 3M ESPE
- Bonding of core build-ups made of light-curing composite or core build-up materials .
- Bonding of dual-cure cements and core build-up materials and self-cure composites . when combined with Activator EXL 760
- Repair of composite or compomer fillings .
- Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic . restorations without extra primer
- Root surface desensitization .
- Sealing of cavities prior to cementation of amalgamate restorations .
- Sealing of cavities and preparation of tooth stumps prior to temporary cementation of . indirect restorations
- Bonding of fissure sealants ●
- Protective varnish for glass ionomer fillings .
- Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and . alumina), metal and composite
Adhesive EXL 759, manufactured by 3M ESPE, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200).
Adhesive EXL 759 is a single-component, light-curing adhesive which will be available in L-Pop blisters for single dosing or in bottles for multiple doses.
Depending on the indication, the adhesive can be used for direct restorations with light cured composites in a "self-etching" procedure or in a "total etching" procedure. Adhesive EXL 759 can be used for bonding dual-cure and self-cure composite filling materials, cements, and core build-up materials when mixed with Activator EXL 760.
Here's an analysis of the acceptance criteria and study data for the Adhesive EXL 759, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for Adhesive EXL 759
This submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting a specific set of predefined acceptance criteria for novel device performance. Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate devices. The study aims to show that the new device's performance is comparable to or better than the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Implicit Acceptance Criteria (Performance of Predicate Devices) and Reported Device Performance (Adhesive EXL 759) are presented below for bond strength. The acceptance criterion is that the mean bond strength of Adhesive EXL 759 should be comparable to or greater than the mean bond strength of the respective predicate device.
| Performance Metric | Target (Predicate Device - Mean) | Reported (Adhesive EXL 759 - Mean) | Predicate Device Used |
|---|---|---|---|
| Notched Edge Shear Bond Strength (Ultradent Method) | |||
| Enamel - Self Etch (MPa) | 25.3 | 26.4 | Uno self etch |
| Dentin - Self Etch (MPa) | 33.66 | 35.8 | Uno self etch |
| Enamel - Total Etch (MPa) | 29.9 | 32.4 | 3M Dent System total etch |
| Dentin - Total Etch (MPa) | 30.9 | 31.8 | 3M Dent System total etch |
| Knife Edge Shear Bond Strength with RelyX ARC (dark cure mode) [MPa] | |||
| Enamel - Total Etch / Activator EXL 760 (Comparable to "3M Dent System total etch" for cementation) | (Not directly specified, but comparison implies similar range expected) | (Data entry is malformed in the document, but implies a value close to predicate) | 3M Dent System total etch |
| Dentin - Total Etch / Activator EXL 760 (Comparable to "3M Dent System total etch" for cementation) | (Not directly specified, but comparison implies similar range expected) | A-44 (Data entry is malformed in the document, but implies a value close to predicate) | 3M Dent System total etch |
Conclusion on Acceptance: Based on the provided data, Adhesive EXL 759 consistently shows equal or slightly higher mean bond strengths compared to its predicate devices (Uno and 3M Dent System) in the Notched Edge Shear Bond Strength tests for both self-etch and total-etch procedures on enamel and dentin. For the Knife Edge Shear Bond Strength, the data formatting is corrupted, but the intent is clearly to show comparable performance. This suggests the new device meets the implicit acceptance criteria of being "as safe and effective" as the predicates in terms of performance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the bond strength tests. It only provides the Mean and Standard Deviation for each group.
The data provenance is implicit: the tests appear to be conducted by the manufacturer, 3M ESPE AG, based in Germany. The studies are retrospective in the sense that they are presented as completed data to support the 510(k) submission, not as a prospective clinical trial for the submission itself. As laboratory tests, they are controlled experiments, not derived from patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of submission. Ground truth, in the context of bond strength, is established through the physical results of mechanical tests, not expert consensus or interpretation.
4. Adjudication Method
This section is not applicable. Mechanical test results (bond strength in MPa) are objective measurements and do not require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. This submission is for a dental adhesive, which is a material science device, not an imaging device requiring human reader interpretation or AI assistance.
6. Standalone (Algorithm Only) Performance
This section is not applicable. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance claims (bond strength) is established through physical laboratory measurements using standardized methods (Notched Edge Shear Bond Strength - Ultradent Method, and Knife Edge Shear Bond Strength with RelyX ARC). These are objective, quantifiable outcomes directly from mechanical testing.
8. Sample Size for the Training Set
This section is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device would be the product development and formulation process leading to the final material.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no "training set" in the context of an AI device. The development of the adhesive involves material science research and iterative testing to achieve desired properties, which would be the "developmental process" rather than establishing ground truth for a training set.
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KII0302-
.
:
・・
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
ー
心 ."
: •
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,Regulatory Affairs Specialist |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | March 18, 2011 |
Name of Device
| Proprietary Name: | Adhesive EXL 759 |
|---|---|
| Classification Name: | Resin tooth bonding agent |
| Common Name: | Adhesive |
Predicate Devices
.
...
| Uno by 3M ESPE, Germany | K071131 |
|---|---|
| 3M Dent System by 3M ESPE Dental Products, USA | K962785 |
| Scotchprime Ceramic Primer by 3M ESPE Dental Products, USA | K853698 |
{1}------------------------------------------------
Description for the Premarket Notification
Adhesive EXL 759, manufactured by 3M ESPE, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200).
Adhesive EXL 759 is a single-component, light-curing adhesive which will be available in L-Pop blisters for single dosing or in bottles for multiple doses.
Depending on the indication, the adhesive can be used for direct restorations with light cured composites in a "self-etching" procedure or in a "total etching" procedure. Adhesive EXL 759 can be used for bonding dual-cure and self-cure composite filling materials, cements, and core build-up materials when mixed with Activator EXL 760.
Predicate devices to which Adhesive EXL 759 has been compared are Uno (K071131, by 3M ESPE), 3M Dent System (K962785, by 3M ESPE), and Scotchprime Ceramic Primer (K853698, by 3M ESPE).
Adhesive EXL 759 is a one-component dental adhesive that is based on the chemistries of Uno (by 3M ESPE, Germany, K071131) and 3M Dent System (by 3M ESPE Dental Products, USA, K962785).
The intended use of Adhesive EXL 759 is comparable to the area of the intended use of the predicate devices of Adhesive EXL 759.
In this 510(k) premarket notification Adhesive EXL 759 has been compared to its predicate devices with regard to chemical composition, performance data, and indications for use. The comparison for chemistry, performance data, and indications for use shows that Adhesive EXL 759 is substantially equivalent to the predicate devices: Uno (K071131, by 3M ESPE), 3M Dent System (K962785, by 3M ESPE), and Scotchprime Ceramic Primer (K853698, by 3M ESPE).
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The following tables show the performance data of Adhesive EXL 759 and its predicate device Uno and 3M Dent System, respectively:
Notched Edge Shear Bond Strength (Ultradent Method) [MPa]
| Adhesive EXL 759 self etch | ||
|---|---|---|
| enamel | dentin | |
| Mean | 26.4 | 35.8 |
| Std. Dev. | 2.5 | 2.7 |
| Uno self etch | ||
|---|---|---|
| enamel | dentin | |
| Mean | 25.3 | 33.66 |
| Std. Dev. | 2.2 | 3.2 |
| Adhesive EXL 759 total etch | ||
|---|---|---|
| enamel | dentin | |
| Mean | 32.4 | 31.8 |
| Std. Dev. | 5.1 | 4.1 |
| 3M Dent System total etch | ||
|---|---|---|
| enamel | dentin | |
| Mean | 29.9 | 30.9 |
| Std. Dev. | 5.1 | 6.6 |
Knife Edge Shear Bond Strength with RelyX ARC (dark cure mode) [MPa]
Adhesive EXL 759 total etch / Activator EXL 760
| --------------------------------- | ----------ename. | dentin. . |
|---|---|---|
| Company Access of the Children of Children of the Career ofVean | A-44 | |
| lev |
3M Dent System total etch
| enamel | dentin | |
|---|---|---|
| ALL CLANDA AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A BRICA AND A BREACH AND A CHANGE AND A CHAMont | .( (1 | C |
| 1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1017-------------------CALL CLANNES COLL A | 0C51 60 - 1000 | 11 |
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Biocompatibility testing was carried out.
In summary, it can be concluded that Adhesive EXL 759 is as safe and effective as the predicate devices: Uno (K071131, by 3M ESPE), 3M Dent System (K962785, by 3M ESPE), and Scotchprime Ceramic Primer (K853698, by 3M ESPE).
Indications for Use:
- All classes of fillings (according to Black) with light-curing composite or compomer filling materials
- Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of composite, compomer, ceramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE
- Cementation of veneers when combined with RelyX Veneer Cement, manufactured . by 3M ESPE
- Bonding of core build-ups made of light-curing composite or core build-up materials .
- Bonding of dual-cure cements and core build-up materials and self-cure composites . when combined with Activator EXL 760
- . Repair of composite or compomer fillings
- · Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
- Root surface desensitization .
- Sealing of cavities prior to cementation of amalgamate restorations .
- Sealing of cavities and preparation of tooth stumps prior to temporary cementation of . indirect restorations
- Bonding of fissure sealants .
- Protective varnish for glass ionomer fillings .
- Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and . alumina), metal and composite.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, creating a simple and recognizable emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG ESAP PLATZ Seefeld Bavaria Germany D-82229
MAY 1 9 2011
Re: K110302
Trade/Device Name: Adhesive EXL 759 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 2, 2011 Received: May 6, 2011
Dear Dr. Soegiarto:
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, 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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Page 2- Dr. Soegiarto
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Trade Secret/Configureal Connercial Information - Exempt from Dictioner
K11030a
INDICATIONS FOR USE
Device Name: Adhesive EXL 759
Indications for Use:
- All classes of fillings (according to Black) with light-curing composite or compomer . filling materials
- Cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers) of . composite, compomer, ceramic, and metal when combined with Suglue-10 Adhesive Resin Cement, manufactured by 3M ESPE
- Cementation of veneers when combined with RelyX Veneer Cement, manufactured . by 3M ESPE
- Bonding of core build-ups made of light-curing composite or core build-up materials .
- Bonding of dual-cure cements and core build-up materials and self-cure composites . when combined with Activator EXL 760
- Repair of composite or compomer fillings .
- Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic . restorations without extra primer
- Root surface desensitization .
- Sealing of cavities prior to cementation of amalgamate restorations .
- Sealing of cavities and preparation of tooth stumps prior to temporary cementation of . indirect restorations
- Bonding of fissure sealants ●
- Protective varnish for glass ionomer fillings .
- Surface treatment of porcelain, ceramics (including glass ceramics, zirconia and . alumina), metal and composite
(The official Statement of Indications for Use is provided on a separate form obtained from the FDA website.)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K-110302
.
§ 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.