(101 days)
Not Found
No
The device description and performance metrics relate to the physical and chemical properties of a dental resin cement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental resin cement used for final cementing of various restorations, not for treating or curing a disease or medical condition.
No
Explanation: The device, Suglue-10, is a resin cement used for final cementing of indirect dental restorations. Its intended use is to bond materials, not to diagnose a condition or disease.
No
The device description clearly states it is a dual-curing resin cement supplied in an automix syringe, which is a physical material, not software. The performance studies also focus on physical properties of the cement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental cement for the final cementing of various dental restorations (inlays, onlays, crowns, bridges, posts, screws, veneers, restorations on implant abutments). This is a direct application within the body for structural support and adhesion.
- Device Description: The description details a dual-curing resin cement used for adhesive cementation of indirect restorations. It mentions its composition (bi-functional (meth)acrylate, inorganic fillers) and how it's used in combination with an adhesive. This aligns with the description of a dental material used for bonding.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. IVDs are used to test samples like blood, urine, tissue, etc., to gain insights into a patient's health status.
The device described is a dental restorative material, specifically a luting cement, used for bonding dental prosthetics to teeth or implants. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
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, or composite veneers
- 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
Suglue-10 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.
Suglue-10, manufactured by 3M ESPE, is a dual-curing resin cement supplied in an automix syringe. It is intended to be used for the adhesive cementation of indirect restorations and will be available in various shades.
Suglue-10 is intended to be used in combination with an adhesive, e.g. Adhesive EXL 759 (by 3M ESPE). The Adhesive EXL 759 can be used either as a "Total Etch" or "Self-Etch" procedure. The additional etching of the tooth structure increases the adhesive strength of the adhesive even further.
Suglue-10 contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43% by volume; the grain size (D 90%) is about 13 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst.
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 document provides performance data for Suglue-10 and its predicate device Malta (K100756) for the following characteristics:
- Film thickness: Suglue-10 10 +/- 2 µm (Limit 60 sec by ISO 4049)
- Setting time: Suglue-10 03:30 min (Limit 1.0 mm by ISO 4049)
- Flexural strength (dark cured): Suglue-10 77 +/- 5 MPa (Limit > 50 MPa by ISO 4049)
- Flexural strength (light cured): Suglue-10 111 +/- 7 MPa (Limit > 50 MPa by ISO 4049)
- Compressive strength (dark cured): Suglue-10 278 +/- 9 MPa (by ISO 9917)
- Compressive strength (light cured): Suglue-10 286 +/- 36 MPa (by ISO 9917)
- Surface hardness (dark cured): Suglue-10 187 +/- 12 MPa (by ISO 2039-1)
- Surface hardness (light cured): Suglue-10 217 +/- 83 MPa (by ISO 2039-1)
Key results: Suglue-10 met or exceeded all specified limits and performed comparably to the predicate device Malta.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Film thickness, Working time, Setting time, Radiopacity, Flexural strength, Compressive strength, Surface hardness.
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.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: K110508
Submitter
JUN - 3 2011
| 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: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | May 04, 2011 |
Name of Device
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| Proprietary Name: | Suglue-10 |
|---|---|
| Classification Name: | Dental cement other than zinc oxide- |
| eugenol | |
| Common Name: | Adhesive resin cement |
Predicate Devices
| Malta by 3M ESPE, Germany | K100756 |
|---|---|
| Panavia F 2.0 by Kuraray Medical Inc., Japan | K032455 |
| Nexus 3 by Kerr Corporation, U.S.A., | K062519 |
1
Description for the Premarket Notification
Suglue-10 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.
Suglue-10, manufactured by 3M ESPE, is a dual-curing resin cement supplied in an automix syringe. It is intended to be used for the adhesive cementation of indirect restorations and will be available in various shades.
Suglue-10 is intended to be used in combination with an adhesive, e.g. Adhesive EXL 759 (by 3M ESPE). The Adhesive EXL 759 can be used either as a "Total Etch" or "Self-Etch" procedure. The additional etching of the tooth structure increases the adhesive strength of the adhesive even further.
Suglue-10 contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 43% by volume; the grain size (D 90%) is about 13 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst.
Predicate devices to which Suglue-10 has been compared are Malta by 3M ESPE, Germany (K100756), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Nexus 3 by Kerr Corporation, U.S.A. (K062519).
Technological Characteristics
As its predicate devices, Suglue-10 is a dual-curing, resin-based cement. Suglue-10 cement is based on the Malta material (K100756, by 3M ESPE, Germany). As Suglue-10 is designed to compete with the latest state of the art adhesive resin cements, its in vitro performance was compared to the newer system Nexus 3 and the still widely used Panavia F2.0.
The intended use of Suglue-10 is comparable to the area of the intended use of the predicate devices of Suglue-10.
In this 510(k) premarket notification Suglue-10 has been compared to its predicate devices with regard to chemical composition, performance data and indications for use.
Biocompatibility testing was carried out.
2
Performance Data
The following table shows the performance data of Suglue-10 and its predicate device Malta (K100756):
| Suglue-10 | Malta | ||||
|---|---|---|---|---|---|
| Method | Limit | Results | |||
| Film thickness | ISO 4049 | 60 sec | pass | pass | |
| Setting time | ISO 4049 | 1.0 mm | 2.3 | 1.8 | |
| Flexural | |||||
| strength | dark cured | ISO 4049 | > 50 MPa | $77 \pm 5$ | $84 \pm 12$ |
| light cured | > 50 MPa | $111 \pm 7$ | $111 \pm 16$ | ||
| Compressive | |||||
| strength | dark cured | ISO 9917 | na [MPa] | $278 \pm 9$ | $263 \pm 9$ |
| light cured | na [MPa] | $286 \pm 36$ | $256 \pm 36$ | ||
| Surface | |||||
| hardness | dark cured | ISO 2039-1 | na [MPa] | $187 \pm 12$ | $190 \pm 20$ |
| light cured | na [MPa] | $217 \pm 83$ | $212 \pm 30$ |
In summary, it can be concluded that Suglue-10 is as safe and effective as the predicate devices: Malta by 3M ESPE, Germany (K100756), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455), and Nexus 3 by Kerr Corporation, U.S.A. (K062519).
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, or composite veneers ●
- Final cementation of all-ceramic, composite, or metal restorations on implant . abutments
3
Conclusion of Substantial Equivalence
The comparison for chemistry, performance data and indications for use shows that Suglue-10 is substantially equivalent to the predicate devices: Malta by 3M ESPE, Germany (K100756), Panavia F 2.0 by Kuraray Medical Inc., Japan (K032455) and Nexus 3 by Kerr Corporation, U.S.A. (K062519).
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Desi W. Soegiarto 3M ESPE AG ESPE Platz Seefeld, Bavaria Germany D-82229
Re: K110508
Trade/Device Name: Suglue-10 Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 16, 2011 Received: May 23, 2011
JUN - 3 2011
Dear Ms. 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- Ms. 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 (OS) 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/ucm 115809.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):
Suglue-10 Device Name:
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, or composite veneers .
- Final cementation of all-ceramic, composite, or metal restorations on . implant abutments
× Prescription Use . {Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K110508