(138 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a composite resin, with no mention of AI or ML technology.
Yes
The device is classified as a temporary crown and bridge resin and is used for the "Fabrication of temporary crowns, bridges, inlays, onlays, and veneers" as well as "long-lasting temporary restorations," which are therapeutic applications.
No
This device is a material used for fabricating temporary dental restorations, not for diagnosing medical conditions.
No
The device description explicitly states that SuPro 100 is a "composite material based on multifunctional methacrylates esters" and a "two-component system," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the fabrication of temporary dental restorations (crowns, bridges, inlays, onlays, veneers). This is a direct application within the mouth for structural purposes.
- Device Description: It is classified as a "temporary crown and bridge resin" and is a composite material used for fabrication.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide information about a person's health. IVDs are used for diagnosis, monitoring, or screening.
This device is a dental material used for creating physical structures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
· Fabrication of temporary crowns, bridges, inlays, onlays, and veneers
· Fabrication of long-lasting temporary restorations
· Lining material for prefabricated temporary crowns made of composite (e.g., Protemp™ Crown) and metal (e.g., Iso-Form crowns)
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
SuPro 100 is classified as temporary crown and bridge resin (21 C.F.R. § 872.3770, Class II device).
As its predicate device TempXN28 (K073296, by 3M Deutschland GmbH - Germany), SuPro 100 is a composite material based on multifunctional methacrylates esters, therefore, both TempXN28 and SuPro 100 as two-component system have filling material-like properties. As TempXN28, Supro 100 will be available in Garant™ mixing and dispensing system (by 3M Deutschland GmbH, Germany).
Main difference between SuPro 100 and TempXN28 is amount of fillers. To improve mechanical properties e.g. flexural strength, e-Modulus and tensile strength, amount of fillers of SuPro 100 is increased in compare to TempXN28 (SuPro 100: approx. 50% of its weight, TempXN28: approx. 33% of its weight).
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)
Investigations have been carried out to characterize the performance of SuPro 100 to be used for fabrication of temporary restorations. Physical and mechanical properties have been compared to properties of TempXN28.
Key Results:
- Flexural strength of SuPro 100 was higher than that of TempXN28.
- e-Modulus of SuPro 100 was higher than that of TempXN28.
- Deflection values of SuPro 100 was comparable to that of TempXN28.
- SuPro 100 shows lower values for compressive strength in compare to that of TempXN28.
- SuPro100 has lower compression percentage at break compared to TempXN28.
- Tensile strength of SuPro 100 was higher than that of TempXN28.
- Value for the elongation till break of SuPro 100 was comparable to that of TempXN28.
- Impact strength of SuPro 100 was comparable to that of TempXN28.
- SuPro 100 had a significantly higher surface hardness compared to TempXN28.
- The maximum temperatures resulting from the polymerization reaction were comparable for SuPro 100 and TempXN28.
- Compared to TempXN28, SuPro 100 generally has a faster setting. Working time, transition time and final setting time are shorter for SuPro 100.
- SuPro 100 had a similar abrasion behavior in the ACTA 3 body wear test in compare to TempXN28.
- SuPro 100 had lower rate of volume loss than TempXN28.
- Abrasion of SuPro 100 is lower than of TempXN28.
- SuPro 100 showed lower rate of wear on the steatite antagonist in compare to TempXN28.
Biocompatibility evaluations have been performed for SuPro 100 in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that SuPro 100 is biocompatible for its intended use.
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.
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
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2015
3M Deutschland GmbH Dr. Desi W. Soegiarto Group Leader Regulatory Affairs ESPE Platz Seefeld, Bavaria 82234
Re: K151144
Trade/Device Name: SuPro 100 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary crown and bridge resin Regulatory Class: II Product Code: EBG Dated: August 05, 2015 Received: July 31, 2015
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.
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name SuPro 100
Indications for Use (Describe)
· Fabrication of temporary crowns, bridges, inlays, onlays, and veneers
· Fabrication of long-lasting temporary restorations
· Lining material for prefabricated temporary crowns made of composite (e.g., Protemp™ Crown) and metal (e.g., Iso-Form crowns)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
3
K151144: 510(k) SUMMARY
Submitter
| Company: | 3M Deutschland GmbH |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent & Contact: | Dr. Desi W. Soegiarto, |
| Regulatory Affairs | |
| Phone: | +49-8152-700 1169 |
| Fax: | +49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | April 27, 2015 |
| (revised on September 10, 2015) |
Name of Device
| Product Code: | EBG |
|---|---|
| Common Name: | Composite based temporary crown and |
| brigde material | |
| Classification: | Crown and Bridge, Temporary, Resin |
| Regulation Number: | 21 CFR 872.3770 |
| Proprietary Name: | SuPro 100 |
Predicate Device
| TempXN28 | K073296 |
|---|---|
| by 3M Deutschland GmbH, Germany |
4
Description for the Premarket Notification
SuPro 100 is classified as temporary crown and bridge resin (21 C.F.R. § 872.3770, Class II device).
As its predicate device TempXN28 (K073296, by 3M Deutschland GmbH - Germany), SuPro 100 is a composite material based on multifunctional methacrylates esters, therefore, both TempXN28 and SuPro 100 as two-component system have filling material-like properties. As TempXN28, Supro 100 will be available in Garant™ mixing and dispensing system (by 3M Deutschland GmbH, Germany).
Investigations have been carried out to characterize the performance of SuPro 100 to be used for fabrication of temporary restorations.
Comparison for indications for use, performance, and chemistry shows that SuPro 100 is substantially equivalent to the predicate device.
Physical and mechanical properties have been compared to properties of TempXN28. Comparison showed that physical and mechanical properties of SuPro 100 are substantially equivalent to TempXN28.
Biocompatibility evaluations have been performed for SuPro 100 in consideration of FDA & internationally recognized guidelines. The conclusion of the assessments is that SuPro 100 is biocompatible for its intended use.
Indications for Use
- Fabrication of temporary crowns, bridges, inlays, onlays, and veneers
- Fabrication of long-lasting temporary restorations .
- . Lining material for prefabricated temporary crowns made of composite (e.g., ProtempTM Crown) and metal (e.g., Iso-Form crowns)
5
| SuPro 100 | TempXN28 (K073296) | |
|---|---|---|
| Indications for Use | Fabrication of temporary | |
| crowns, bridges, inlays, | ||
| onlays, and veneers | Fabrication of temporary | |
| crowns, bridges, inlays, | ||
| onlays, and veneers | ||
| Fabrication of long- | ||
| lasting temporary | ||
| restorations | Fabrication of long- | |
| lasting temporary | ||
| restorations | ||
| Lining material for | ||
| prefabricated temporary | ||
| crowns made of | ||
| composite (e.g., | ||
| Protemp™ Crown) and | ||
| metal (e.g., Iso-Form | ||
| crowns) | Lining material for | |
| prefabricated temporary | ||
| crowns made of | ||
| composite (e.g., | ||
| Protemp™ Crown) and | ||
| metal (e.g., Iso-Form | ||
| crowns) | ||
| SuPro 100 | TempXN28 (K073296) | |
| Technological | ||
| Characteristic | Delivery: Garant™ | |
| mixing and dispensing | ||
| system | Delivery: Garant™ | |
| mixing and dispensing | ||
| system | ||
| Composite material | ||
| based on multifunctional | ||
| methacrylate esters | Composite material | |
| based on multifunctional | ||
| methacrylate esters | ||
| Two component system: | ||
| Base paste and catalyst | ||
| paste | Two component system: | |
| Base paste and catalyst | ||
| paste |
Tab. Substantial equivalence: Comparisons
6
| Test | Results |
|---|---|
| Flexural strength [MPa] | Flexural strength of SuPro 100 was higher than that |
| of TempXN28. | |
| e-Modulus [GPa] | e-Modulus of SuPro 100 was higher than that of |
| TempXN28. | |
| Deflection [mm] | Deflection values of SuPro 100 was comparable to |
| that of TempXN28. | |
| Compression strength [MPa] | SuPro 100 shows lower values for compressive |
| strength in compare to that of TempXN28. | |
| Compression at break [%] | SuPro100 has lower compression percentage at |
| break compared to TempXN28. | |
| Tensile strength [MPa] | Tensile strength of SuPro 100 was higher than that |
| of TempXN28. | |
| Elongation at break [%] | Value for the elongation till break of SuPro 100 was |
| comparable to that of TempXN28. | |
| Impact strength [kJ/mm²] | Impact strength of SuPro 100 was comparable to |
| that of TempXN28. | |
| Surface hardness (Vickers scale): 1d, | |
| 36°C in water & 4d, 36°C in water | SuPro 100 had a significantly higher surface |
| hardness compared to TempXN28. | |
| Temperature peak (1cm³ Volume) | |
| [°C] | The maximum temperatures resulting from the |
| polymerization reaction were comparable for SuPro | |
| 100 and TempXN28. | |
| Setting characteristics (Physica; | |
| 23°C). Working time (tA) [min], | |
| Final setting (tE) [min], Setting | |
| transition (dt) [min] | Compared to TempXN28, SuPro 100 generally has a |
| faster setting. Working time, transition time and | |
| final setting time are shorter for SuPro 100. | |
| ACTA abrasion (3 body wear) | SuPro 100 had a similar abrasion behavior in the |
| ACTA 3 body wear test in compare to TempXN28. | |
| Chewing simulation volume loss | |
| [µm³] | SuPro 100 had lower rate of volume loss than |
| TempXN28. | |
| Elcometer Abrasion depths samples | |
| [µm] | Abrasion of SuPro 100 is lower than of TempXN28. |
| Elcometer Volume loss steatite | |
| antagonist [mm] | SuPro 100 showed lower rate of wear on the steatite |
| antagonist in compare to TempXN28. |
7
Following Standards have been referenced for both SuPro 100 and the predicate device TempXN28 (K073296):
There are no standards specifically for temporary crown and bridge materials. Therefore, for some material testing standards were referenced: ISO 179-1, ISO 527-1, ISO 4049, ISO 9917.
Biocompatibility: ISO 7405, ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-12
Risk Management: ISO 14971
Main difference between SuPro 100 and TempXN28 is amount of fillers. To improve mechanical properties e.g. flexural strength, e-Modulus and tensile strength, amount of fillers of SuPro 100 is increased in compare to TempXN28 (SuPro 100: approx. 50% of its weight, TempXN28: approx. 33% of its weight).
SuPro 100 and its predicate device TempXN28 (K073296) are very similar in material class, composition, and technology. SuPro 100 and TempXN28 have same indications for use and procedure as bis-acrylic composite dental temporary materials. Comparisons showed that physical and mechanical properties of SuPro 100 are comparable to those of TempXN28. Both SuPro 100 and TempXN28 are biocompatible for its intended use. In summary, it can be concluded that SuPro 100 is substantially equivalent to the predicate device TempXN28 (K073296).