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
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.
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.
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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# KII0302-
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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: | 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 |
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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
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|-------------------------------------------------------------------------|--------------------------|--------------------|
| <br>Company Access of the Children of Children of the Career of<br>Vean | | A-44 |
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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 (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
.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
