(77 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a dental cement, with no mention of AI or ML capabilities.
No
The device is a resin cement used for final cementing of dental restorations, which is a structural rather than a therapeutic function.
No
Explanation: The device, Malta, is described as a "dual-curing, self-adhesive resin cement" used for "final cementing" of various dental restorations. Its intended use is to bond materials, not to diagnose conditions or diseases. The performance studies and key metrics relate to the physical properties of the cement, such as film thickness, setting time, and strength, which are characteristic of materials, not diagnostic tools.
No
The device description clearly describes a physical material (resin cement) and its components, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the final cementing of dental restorations (inlays, onlays, crowns, bridges, posts, screws) and restorations on implant abutments. This is a direct application within the patient's mouth for structural and restorative purposes.
- Device Description: The device is a dual-curing, self-adhesive resin cement. This is a material used for bonding within the oral cavity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for a restorative dental procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EMA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following table shows the performance data of Malta and its predicate device Unicem:
Film thickness: ISO 4049:2000, Limit 1.0 mm, Malta results: 1.8, Unicem results: 2.4
Flexural strength: dark cured: ISO 4049:2000, Limit > 50 MPa, Malta results: 84 ± 12, Unicem results: 53 ± 7
Flexural strength: light cured: ISO 4049:2000, Limit > 50 MPa, Malta results: 111 ± 16, Unicem results: 64 ± 6
Compressive strength: dark cured: ISO 9917:2001, Limit na [MPa], Malta results: 263 ± 9, Unicem results: 209 ± 15
Compressive strength: light cured: ISO 9917:2001, Limit na [MPa], Malta results: 256 ± 36, Unicem results: 218 ± 13
Surface hardness: dark cured: ISO 2039-1:2000, Limit na [MPa], Malta results: 190 ± 20, Unicem results: 209 ± 13
Surface hardness: light cured: ISO 2039-1:2000, Limit na [MPa], Malta results: 212 ± 30, Unicem results: 151 ± 10
Biocompatibility testing was carried out.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K020256, K094007, K032455, K073209
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
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).
2
| Method | Limit | Malta | Unicem | ||
|---|---|---|---|---|---|
| Results | |||||
| Film thickness | ISO 4049:2000 | 1.0 mm | 1.8 | 2.4 | |
| Flexural | |||||
| strength | dark cured | ISO 4049:2000 | > 50 MPa | 84 ± 12 | 53 ± 7 |
| light cured | > 50 MPa | 111 ± 16 | 64 ± 6 | ||
| Compressive | |||||
| strength | dark cured | ISO 9917:2001 | na [MPa] | 263 ± 9 | 209 ± 15 |
| light cured | na [MPa] | 256 ± 36 | 218 ± 13 | ||
| Surface | |||||
| 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).
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.
5
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
6
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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