MALTA

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

Intended 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.

Predicate Devices

• Unicem by 3M ESPE (K020256, K094007)
• Panavia F 2.0 by Kuraray Medical Inc. (K032455)
• Maxcem 2 by Kerr Corporation (K073209)

Submission Summary (Full Text)

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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: | [e-mail] |
| 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 [phone] or [phone] 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

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