SuPro 100

K151144 · 3M Deutschland GmbH · EBG · Sep 14, 2015 · Dental

Device Facts

• Record ID: K151144
• Device Name: SuPro 100
• Applicant: 3M Deutschland GmbH
• Product Code: EBG · Dental
• Decision Date: Sep 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended 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)

Device Story

SuPro 100 is a two-component composite material based on multifunctional methacrylate esters used for fabricating temporary dental restorations. It is delivered via the Garant™ mixing and dispensing system. The device is used in a dental clinic setting by a dentist or dental professional. The material is mixed and applied to create temporary crowns, bridges, inlays, onlays, and veneers, or to line prefabricated crowns. The clinician uses the material to provide patients with functional, long-lasting temporary restorations during the interim period before permanent restoration placement. The increased filler content (approx. 50% by weight) compared to the predicate improves mechanical properties like flexural strength, e-Modulus, and tensile strength, potentially benefiting the patient through increased durability of the temporary restoration.

Clinical Evidence

Bench testing only. Physical and mechanical properties compared to predicate included flexural strength, e-Modulus, compressive strength, tensile strength, impact strength, surface hardness, and abrasion behavior. Biocompatibility evaluated per ISO 7405 and ISO 10993 series. Results indicate SuPro 100 has higher flexural strength, e-Modulus, and tensile strength, and comparable impact strength and abrasion behavior to the predicate.

Technological Characteristics

Two-component composite material based on multifunctional methacrylate esters. Delivery via Garant™ mixing and dispensing system. Filler content approx. 50% by weight. Standards referenced: ISO 179-1, ISO 527-1, ISO 4049, ISO 9917, ISO 7405, ISO 10993 series, and ISO 14971 for risk management.

Indications for Use

Indicated for dental patients requiring temporary restorations including crowns, bridges, inlays, onlays, veneers, and lining for prefabricated temporary crowns.

Regulatory Classification

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.

Predicate Devices

• TempXN28 (K073296)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K151144

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,<br>Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date: | April 27, 2015<br>(revised on September 10, 2015) |

## Name of Device

| Product Code: | EBG |
|--------------------|--------------------------------------------------------|
| Common Name: | Composite based temporary crown and<br>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 |

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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 temporary<br>crowns, bridges, inlays,<br>onlays, and veneers | Fabrication of temporary<br>crowns, bridges, inlays,<br>onlays, and veneers |
| | Fabrication of long-<br>lasting temporary<br>restorations | Fabrication of long-<br>lasting temporary<br>restorations |
| | Lining material for<br>prefabricated temporary<br>crowns made of<br>composite (e.g.,<br>Protemp™ Crown) and<br>metal (e.g., Iso-Form<br>crowns) | Lining material for<br>prefabricated temporary<br>crowns made of<br>composite (e.g.,<br>Protemp™ Crown) and<br>metal (e.g., Iso-Form<br>crowns) |
| | | |
| | SuPro 100 | TempXN28 (K073296) |
| Technological<br>Characteristic | Delivery: Garant™<br>mixing and dispensing<br>system | Delivery: Garant™<br>mixing and dispensing<br>system |
| | Composite material<br>based on multifunctional<br>methacrylate esters | Composite material<br>based on multifunctional<br>methacrylate esters |
| | Two component system:<br>Base paste and catalyst<br>paste | Two component system:<br>Base paste and catalyst<br>paste |

# Tab. Substantial equivalence: Comparisons

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| Test | Results |
|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flexural strength [MPa] | Flexural strength of SuPro 100 was higher than that<br>of TempXN28. |
| e-Modulus [GPa] | e-Modulus of SuPro 100 was higher than that of<br>TempXN28. |
| Deflection [mm] | Deflection values of SuPro 100 was comparable to<br>that of TempXN28. |
| Compression strength [MPa] | SuPro 100 shows lower values for compressive<br>strength in compare to that of TempXN28. |
| Compression at break [%] | SuPro100 has lower compression percentage at<br>break compared to TempXN28. |
| Tensile strength [MPa] | Tensile strength of SuPro 100 was higher than that<br>of TempXN28. |
| Elongation at break [%] | Value for the elongation till break of SuPro 100 was<br>comparable to that of TempXN28. |
| Impact strength [kJ/mm²] | Impact strength of SuPro 100 was comparable to<br>that of TempXN28. |
| Surface hardness (Vickers scale): 1d,<br>36°C in water & 4d, 36°C in water | SuPro 100 had a significantly higher surface<br>hardness compared to TempXN28. |
| Temperature peak (1cm³ Volume)<br>[°C] | The maximum temperatures resulting from the<br>polymerization reaction were comparable for SuPro<br>100 and TempXN28. |
| Setting characteristics (Physica;<br>23°C). Working time (tA) [min],<br>Final setting (tE) [min], Setting<br>transition (dt) [min] | Compared to TempXN28, SuPro 100 generally has a<br>faster setting. Working time, transition time and<br>final setting time are shorter for SuPro 100. |
| ACTA abrasion (3 body wear) | SuPro 100 had a similar abrasion behavior in the<br>ACTA 3 body wear test in compare to TempXN28. |
| Chewing simulation volume loss<br>[µm³] | SuPro 100 had lower rate of volume loss than<br>TempXN28. |
| Elcometer Abrasion depths samples<br>[µm] | Abrasion of SuPro 100 is lower than of TempXN28. |
| Elcometer Volume loss steatite<br>antagonist [mm] | SuPro 100 showed lower rate of wear on the steatite<br>antagonist 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).