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 Description

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.

AI/ML Overview

The provided text describes a dental cement product called "Malta" and its performance characteristics, comparing it to predicate devices to establish substantial equivalence for regulatory purposes. However, it does not contain information about a study involving an AI device or a comparative effectiveness study with human readers.

Therefore, I can only provide information related to the acceptance criteria and performance data for the dental cement "Malta," as well as details about the study that demonstrates this performance. Questions pertaining to AI, human readers, ground truth for AI, training sets for AI, or adjudication methods are not applicable based on the provided text.

Here's the information derived from the provided text regarding the dental cement Malta:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Method	Acceptance Criteria (Limit)	Reported Performance (Malta)
Film thickness	ISO 4049:2000	< 50 µm	13 ± 1 µm
Setting time	ISO 4049:2000	< 10 min	03:30 min
Radiopacity	ISO 4049:2000	> 1.0 mm	1.8 mm
Flexural strength (dark cured)	ISO 4049:2000	> 50 MPa	84 ± 12 MPa
Flexural strength (light cured)	ISO 4049:2000	> 50 MPa	111 ± 16 MPa
Compressive strength (dark cured)	ISO 9917:2001	Not applicable (na)	263 ± 9 MPa
Compressive strength (light cured)	ISO 9917:2001	Not applicable (na)	256 ± 36 MPa
Surface hardness (dark cured)	ISO 2039-1:2000	Not applicable (na)	190 ± 20 MPa
Surface hardness (light cured)	ISO 2039-1:2000	Not applicable (na)	212 ± 30 MPa

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test or the specific data provenance (e.g., country of origin, retrospective/prospective) for these tests. It only states that "Biocompatibility testing was carried out." and presents performance data alongside predicate device data. These tests were likely conducted under controlled laboratory conditions to meet ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The study is a laboratory-based performance evaluation of a dental material, not a clinical study requiring expert diagnosis or ground truth establishment in that typical sense. The "ground truth" here is the physical and mechanical properties of the material determined by standardized testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods typically apply to studies where human interpretation or classification is involved, such as medical imaging analysis. The presented data are objective measurements from laboratory tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The document describes a dental cement, not an AI device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The document describes a dental cement, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context refers to the objectively measured physical and mechanical properties of the dental cement, established through standardized laboratory testing procedures defined by ISO (International Organization for Standardization) standards (e.g., ISO 4049:2000, ISO 9917:2001, ISO 2039-1:2000).

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI or machine learning study.

9. How the ground truth for the training set was established

This question is not applicable. There is no mention of a "training set" or "ground truth" in the context of an AI study. The performance data for Malta was established through direct measurement using recognized international standards.

Summary

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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,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-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 ..........................................................................................................................................

{1}------------------------------------------------

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.

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).

{2}------------------------------------------------

		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
Flexuralstrength	dark cured	ISO 4049:2000	> 50 MPa	84 ± 12	53 ± 7
	light cured		> 50 MPa	111 ± 16	64 ± 6
Compressivestrength	dark cured	ISO 9917:2001	na [MPa]	263 ± 9	209 ± 15
	light cured		na [MPa]	256 ± 36	218 ± 13
Surfacehardness	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).

{3}------------------------------------------------

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.

{4}------------------------------------------------

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

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

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.