ADHESIVE EXL-759

K110302 · 3M Espe AG · KLE · May 19, 2011 · Dental

Device Facts

• Record ID: K110302
• Device Name: ADHESIVE EXL-759
• Applicant: 3M Espe AG
• Product Code: KLE · Dental
• Decision Date: May 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended 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.

Device Story

Adhesive EXL 759 is a single-component, light-curing dental adhesive; available in L-Pop blisters or bottles. Used by dentists in clinical settings for direct/indirect restorations. Operates via self-etching or total-etching procedures; compatible with light-cure, dual-cure, and self-cure materials when mixed with Activator EXL 760. Applied to tooth structure or restorative surfaces to facilitate bonding of composites, compomers, ceramics, and metals. Provides clinical benefits by enabling durable adhesion, cavity sealing, and desensitization. Healthcare providers apply the adhesive to the prepared site, followed by light-curing or chemical activation, to secure restorative materials, thereby restoring tooth function and aesthetics.

Clinical Evidence

Bench testing only. Performance evaluated via Notched Edge Shear Bond Strength (Ultradent Method) and Knife Edge Shear Bond Strength. Results compared Adhesive EXL 759 against Uno and 3M Dent System in both enamel and dentin substrates. Mean bond strengths for EXL 759 ranged from 26.4 to 35.8 MPa (self-etch) and 31.8 to 32.4 MPa (total-etch), demonstrating performance comparable to predicate devices. Biocompatibility testing was also conducted.

Technological Characteristics

Single-component, light-curing resin tooth bonding agent. Formulated for self-etch or total-etch procedures. Compatible with Activator EXL 760 for dual/self-cure applications. Delivered in L-Pop blisters or bottles. Class II device (21 CFR 872.3200).

Indications for Use

Indicated for dental patients requiring restorative procedures including: all classes of fillings (Black's classification), cementation of indirect restorations (inlays, onlays, crowns, bridges, veneers), bonding of core build-ups, repair of composite/compomer fillings, intraoral repair of restorations (porcelain fused to metal, all-ceramic), root surface desensitization, cavity sealing, fissure sealant bonding, and surface treatment of dental materials (porcelain, ceramics, zirconia, alumina, metal, composite).

Regulatory Classification

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.

Predicate Devices

• Uno by 3M ESPE (K071131)
• 3M Dent System by 3M ESPE Dental Products (K962785)
• Scotchprime Ceramic Primer by 3M ESPE Dental Products (K853698)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Submitter

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| 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,<br>Regulatory Affairs Specialist |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| 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 |

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#### 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

| --------------------------------- | ----------<br>ename.<br> | dentin<br><br>. . |
|-------------------------------------------------------------------------|--------------------------|--------------------|
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3M Dent System total etch

| | enamel | dentin<br><br> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------|
| 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 CHA<br>Mont | .<br>( (<br>1 | C |
| 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>017<br>-------------------<br>CALL CLANNES COLL A | 0<br>C<br>5<br>1 60 - 1000 | 1<br>1 |

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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.

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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 [phone] or [phone] 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

.