(138 days)
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)
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).
This is a 510(k) summary for a dental temporary restorative material, SuPro 100. The document focuses on demonstrating substantial equivalence to a predicate device (TempXN28) rather than providing detailed acceptance criteria and a study report in the format typically seen for AI/ML-driven medical devices.
Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI) are not applicable to this type of regulatory submission because it is for a physical dental material, not a software device or AI algorithm.
However, I can extract the acceptance criteria (in terms of performance comparisons) and summarize the "study" (i.e., the physical and mechanical testing performed).
Acceptance Criteria and Device Performance for SuPro 100
The acceptance criteria for SuPro 100 are based on demonstrating "substantial equivalence" to the predicate device, TempXN28 (K073296), in terms of physical and mechanical properties, as well as biocompatibility and indications for use. The "study" refers to the series of laboratory tests conducted on SuPro 100 and TempXN28 to compare their performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name (Acceptance Criteria Implicitly: Comparable or Improved vs. Predicate) | Reported Performance of SuPro 100 vs. TempXN28 |
|---|---|
| Mechanical Properties | |
| Flexural strength [MPa] | Higher than TempXN28 |
| e-Modulus [GPa] | Higher than TempXN28 |
| Deflection [mm] | Comparable to TempXN28 |
| Compression strength [MPa] | Lower than TempXN28 |
| Compression at break [%] | Lower than TempXN28 |
| Tensile strength [MPa] | Higher than TempXN28 |
| Elongation at break [%] | Comparable to TempXN28 |
| Impact strength [kJ/mm²] | Comparable to TempXN28 |
| Surface hardness (Vickers scale) | Significantly higher than TempXN28 |
| Setting Characteristics | |
| Temperature peak (1cm³ Volume) [°C] | Comparable to TempXN28 |
| Setting characteristics (Working time, Final setting, Setting transition) | Faster setting (shorter working time, transition time, and final setting time) compared to TempXN28 |
| Abrasion Properties | |
| ACTA abrasion (3 body wear) | Similar abrasion behavior to TempXN28 |
| Chewing simulation volume loss [µm³] | Lower rate of volume loss than TempXN28 |
| Elcometer Abrasion depths samples [µm] | Lower than TempXN28 |
| Elcometer Volume loss steatite antagonist [mm] | Lower rate of wear on steatite antagonist compared to TempXN28 |
| Other | |
| Biocompatibility | Biocompatible for intended use (based on ISO 7405, ISO 10993 series testing), comparable to predicate's known biocompatibility. |
| Indications for Use | Same as TempXN28 |
| Material Class, Composition, Technology | Very similar to TempXN28 |
| Delivery System | Same as TempXN28 (Garant™ mixing and dispensing system) |
Summary of "Acceptance Criteria" for Substantial Equivalence:
The implied acceptance criterion is that SuPro 100 must either demonstrate comparable performance or, ideally, superior performance in key mechanical and physical properties while maintaining similar handling characteristics (like setting time within a functional range), biocompatibility, and intended uses as the predicate device. For several key mechanical properties (flexural strength, e-Modulus, tensile strength, surface hardness), SuPro 100 showed higher values, which is considered an improvement. For other properties, it was "comparable" or "similar." Faster setting time is a characteristic difference. Lower compression strength and compression at break were noted, but the overall conclusion was still substantial equivalence, likely because other reinforcing properties were improved.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the 510(k) summary. For physical and mechanical tests of materials, established dental material standards (e.g., ISO) typically specify minimum sample sizes for each test type (e.g., n=5 or n=10 per group). Given the reference to ISO standards, it is highly likely that suitable sample sizes were used in accordance with those standards.
- Data Provenance: The tests were conducted by 3M Deutschland GmbH in Germany. This is a prospective testing of the manufactured material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a material testing submission, not a diagnostic device involving expert interpretation of data or images. The "ground truth" for material properties is established through standardized laboratory measurements and physical tests referencing ISO standards.
4. Adjudication method for the test set:
- Not Applicable. See point 3.
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:
- Not Applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Objective Material Property Measurements: The "ground truth" for the performance comparisons comes from direct laboratory measurements of physical, mechanical, and chemical properties of the material, as defined by international standards (e.g., ISO 179-1, ISO 527-1, ISO 4049, ISO 9917 for physical/mechanical; ISO 7405, ISO 10993 series for biocompatibility).
8. The sample size for the training set:
- Not Applicable. This is a physical material, not an AI/ML model. There is no concept of a "training set" in this context. The formulation of the material and its properties are developed through R&D (research and development) processes.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8. The "ground truth" for material development is based on scientific principles of polymer chemistry and material science to achieve desired properties.
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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.
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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
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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)
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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 andbrigde 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 |
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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)
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| SuPro 100 | TempXN28 (K073296) | |
|---|---|---|
| Indications for Use | Fabrication of temporarycrowns, bridges, inlays,onlays, and veneers | Fabrication of temporarycrowns, bridges, inlays,onlays, and veneers |
| Fabrication of long-lasting temporaryrestorations | Fabrication of long-lasting temporaryrestorations | |
| Lining material forprefabricated temporarycrowns made ofcomposite (e.g.,Protemp™ Crown) andmetal (e.g., Iso-Formcrowns) | Lining material forprefabricated temporarycrowns made ofcomposite (e.g.,Protemp™ Crown) andmetal (e.g., Iso-Formcrowns) | |
| SuPro 100 | TempXN28 (K073296) | |
| TechnologicalCharacteristic | Delivery: Garant™mixing and dispensingsystem | Delivery: Garant™mixing and dispensingsystem |
| Composite materialbased on multifunctionalmethacrylate esters | Composite materialbased on multifunctionalmethacrylate esters | |
| Two component system:Base paste and catalystpaste | Two component system:Base paste and catalystpaste |
Tab. Substantial equivalence: Comparisons
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| Test | Results |
|---|---|
| Flexural strength [MPa] | Flexural strength of SuPro 100 was higher than thatof TempXN28. |
| e-Modulus [GPa] | e-Modulus of SuPro 100 was higher than that ofTempXN28. |
| Deflection [mm] | Deflection values of SuPro 100 was comparable tothat of TempXN28. |
| Compression strength [MPa] | SuPro 100 shows lower values for compressivestrength in compare to that of TempXN28. |
| Compression at break [%] | SuPro100 has lower compression percentage atbreak compared to TempXN28. |
| Tensile strength [MPa] | Tensile strength of SuPro 100 was higher than thatof TempXN28. |
| Elongation at break [%] | Value for the elongation till break of SuPro 100 wascomparable to that of TempXN28. |
| Impact strength [kJ/mm²] | Impact strength of SuPro 100 was comparable tothat of TempXN28. |
| Surface hardness (Vickers scale): 1d,36°C in water & 4d, 36°C in water | SuPro 100 had a significantly higher surfacehardness compared to TempXN28. |
| Temperature peak (1cm³ Volume)[°C] | The maximum temperatures resulting from thepolymerization reaction were comparable for SuPro100 and TempXN28. |
| Setting characteristics (Physica;23°C). Working time (tA) [min],Final setting (tE) [min], Settingtransition (dt) [min] | Compared to TempXN28, SuPro 100 generally has afaster setting. Working time, transition time andfinal setting time are shorter for SuPro 100. |
| ACTA abrasion (3 body wear) | SuPro 100 had a similar abrasion behavior in theACTA 3 body wear test in compare to TempXN28. |
| Chewing simulation volume loss[µm³] | SuPro 100 had lower rate of volume loss thanTempXN28. |
| Elcometer Abrasion depths samples[µm] | Abrasion of SuPro 100 is lower than of TempXN28. |
| Elcometer Volume loss steatiteantagonist [mm] | SuPro 100 showed lower rate of wear on the steatiteantagonist in compare to TempXN28. |
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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).
§ 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.