K100756 · 3M Espe AG Dental Products · EMA · Jun 2, 2010 · Dental
Device Facts
Record ID
K100756
Device Name
MALTA
Applicant
3M Espe AG Dental Products
Product Code
EMA · Dental
Decision Date
Jun 2, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3275
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
Device Story
Malta is a dual-curing, self-adhesive resin cement used by dental professionals for final restoration cementation. The device consists of a bi-functional (meth)acrylate resin with approximately 70% inorganic filler by weight. It is supplied in an automix syringe, where a base paste and catalyst paste are mixed at a 1:1 volume ratio via a static single-use mixer. The cement is applied to dental restorations (inlays, onlays, crowns, bridges, posts, screws, or implant abutments) to bond them to tooth structure or implant components. The dual-curing mechanism allows for polymerization via light-curing or chemical-curing. The device provides mechanical fixation and radiopacity, aiding in clinical restoration stability and long-term dental health.
Clinical Evidence
Bench testing only. Performance evaluated against ISO 4049:2000, ISO 9917:2001, and ISO 2039-1:2000 standards. Metrics included film thickness (13 ± 1 μm), setting time (03:30), radiopacity (1.8 mm), flexural strength (84-111 MPa), compressive strength (256-263 MPa), and surface hardness (190-212 MPa). Biocompatibility testing was performed.
Technological Characteristics
Dual-curing, self-adhesive resin cement. Composition: bi-functional (meth)acrylate, ~70% inorganic filler by weight (12.5 µm grain size). Delivery: automix syringe with static mixer. Standards: ISO 4049:2000 (film thickness, setting time, radiopacity, flexural strength), ISO 9917:2001 (compressive strength), ISO 2039-1:2000 (surface hardness).
Indications for Use
Indicated for final cementation of all-ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, screws, and implant abutment restorations. Contraindicated for patients with bruxism or periodontitis regarding 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges.
Regulatory Classification
Identification
Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
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# 0756
## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## Submitter
| 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: | May 18, 2010 |
| | JUN =2 2010 |
#### Name of Device
| Proprietary Name: | Malta |
|----------------------|-------------------------------------------------|
| Classification Name: | Dental cement other than zinc oxide-<br>eugenol |
| Common Name: | Self adhesive cement |
#### Predicate Devices
Unicem by 3M ESPE, Germany ................................................................................................................................................... Panavia F 2.0 by Kuraray Medical Inc., Japan ................................................................................................................................. Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite ..........................................................................................................................................
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#### Description for the Premarket Notification
Malta is classified as a Dental cement other than zinc oxide-eugenol (21 C.F.R. §872.3275 {b]) because it is a device composed of various materials other than zinc oxide-eugenol.
Malta is a dual-curing, self-adhesive resin cement available in an automix syringe. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70 % by weight; the grain size (D 90 %) is about 12.5 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. The two pastes are mixed by a static single use mixer attached to the syringe. Malta is available in various shades.
Predicate devices to which Malta has been compared are Unicem by 3M ESPE, Germany (K020256, K094007), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
As its predicate devices, Malta is a dual-curing, resin-based cement. Like Maxcem Elite, Malta is a paste/paste product offered in an automix delivery system.
The intended use of Malta is comparable to the area of the intended use of the predicate devices of Malta.
In this 510(k) premarket notification Malta 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 Malta is substantially equivalent to the predicate devices: Unicem by 3M ESPE, Germany (K020256, K094007), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
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| | | Method | Limit | Malta | Unicem |
|-------------------------|-------------|-----------------|----------|----------|----------|
| | | | | Results | |
| Film thickness | | ISO 4049:2000 | < 50 μm | 13 ± 1 | 12 ± 2 |
| Setting time | | ISO 4049:2000 | < 10 min | 03:30 | 05:00 |
| Radiopacity | | ISO 4049:2000 | > 1.0 mm | 1.8 | 2.4 |
| Flexural<br>strength | dark cured | ISO 4049:2000 | > 50 MPa | 84 ± 12 | 53 ± 7 |
| | light cured | | > 50 MPa | 111 ± 16 | 64 ± 6 |
| Compressive<br>strength | dark cured | ISO 9917:2001 | na [MPa] | 263 ± 9 | 209 ± 15 |
| | light cured | | na [MPa] | 256 ± 36 | 218 ± 13 |
| Surface<br>hardness | dark cured | ISO 2039-1:2000 | na [MPa] | 190 ± 20 | 209 ± 13 |
| | light cured | | na [MPa] | 212 ± 30 | 151 ± 10 |
The following table shows the performance data of Malta and its predicate device Unicem:
Biocompatibility testing was carried out.
In summary, it can be concluded that Malta is as safe and effective as the predicate devices: Unicem by 3M ESPE, Germany (K020256, K094007), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Maxcem 2 by Kerr Corporation, U.S.A., presumably marketed as Maxcem Elite (K073209).
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### Indications for Use:
Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis);
Final cementing of posts and screws;
Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Desi Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria Germany D-82229
JUN - 2 2010
Re: K100756
Trade/Device Name: Malta Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 12, 2010 Received: March 17, 2010
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 vours.
Wh 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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# Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
K 100756
#### Malta
Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.
Prescription Use X (Part 21 CFR 801 Subpart Dj
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF VEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
K.Bettz DDS for Dr. K.P. Mulry
(Division Sign-Off)
Division of Anesthesiology, General Hospita Infection Control, Dental Devices
510(k) Number: K100756
1 Page 1 of
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.
