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K Number
K141562
Device Name
MSN-006
Manufacturer
GC AMERICA, INC.
Date Cleared
2014-09-05

(85 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K073296,K101710,K082434,K073283,K123631
Predicate For
K193113
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers
    1. Fabrication of long-term temporary restorations
Device Description

MSN-006 is a dual-cured, temporary crown and bridge resin. The components consists of Paste A and B, which are filled in a cartridge. Both pastes are automixed with a mixing tip.

AI/ML Overview

This is a 510(k) summary for a dental device, MSN-006, a temporary crown and bridge resin. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through bench testing against an international standard. As such, it does not involve AI or algorithms, human readers, or clinical studies with ground truth established by experts or pathology.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information provided in this document.

However, I can provide the acceptance criteria and performance based on the bench testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the international standard ISO 10477: 2004 (Dentistry - Polymer-based crown and bridge materials). The document states that the applicant device (MSN-006) complies with all the requirements of this standard. While specific numerical acceptance criteria from ISO 10477 are not explicitly listed in the document, it broadly states that "Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477". It also notes "Differences in Flexural Strength, Water Sorption and Solubility are noted" but still confirms compliance with ISO 10477.

CharacteristicAcceptance Criteria (from ISO 10477)Reported Device Performance (MSN-006)
Flexural StrengthMeets ISO 10477 requirementsMeets or exceeds ISO 10477 requirements (differences noted but compliant)
Water SorptionMeets ISO 10477 requirementsMeets or exceeds ISO 10477 requirements (differences noted but compliant)
SolubilityMeets ISO 10477 requirementsMeets or exceeds ISO 10477 requirements (differences noted but compliant)
Other characteristics of polymer-based crown and bridge materialsMeets ISO 10477 requirementsComplies with all requirements of ISO 10477

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a bench top testing regimen. The document explicitly states: "Bench top testing indicates that even with different formulas, applicant device and predicate devices previously mentioned, meet specifications listed in ISO 10477 (Section 18)." and "In summary, indications for previously mentioned predicate devices and applicant device are the same. Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477 (Section 18)."

Remaining Information (Not Applicable to this Document):

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.

4. Adjudication method for the test set: Not applicable.

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/algorithm-based device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used: Not applicable. For bench testing, the "ground truth" is adherence to the scientific and technical specifications of the ISO standard.

8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm-based device.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures in profile forming the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

GC America, Inc. Mark Heiss, DDS Director, Regulatory Affairs & Academic Affairs, and Professional Relations 3737 West 127th Street Alsip, IL 60803

Re: K141562 Trade/Device Name: MSN-006 Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: June 23, 2014 Received: June 25, 2014

Dear Dr. Heiss:

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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Page 2 - Dr. Heiss

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

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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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K141562

Device Name: MSN-006

Indications for Use:

    1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers
    1. Fabrication of long-term temporary restorations

Prescription Use X (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)

Page 4.1 of 4.1

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Image /page/3/Picture/1 description: The image shows the text "'GC'" in a stylized, green font. The letters are bold and slightly italicized, giving them a dynamic appearance. The single quotation marks are also in green and placed at the beginning and end of the text.

GC AMERICA INC.
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 371-5103

  • Submitter Information: 1.
    GC AMERICA INC.
    3737 W. 127ª Street Alsip, IL 60803
Contact Person:Mark Heiss, D.D.S.
Phone:(708) 926-3090
Fax:(708) 926-9100
Date Prepared:June 10, 2014
  • Device Name: 2.
Proprietary Name:MSN-006
Classification Name:Crown and Bridge, Temporary, Resin
Device Classification:Class II, 872.3770
Product Code:EBG
  • Predicate Devices: 3.
CompanyDevice510(k) No.Date Cleared
3M ESPE AG DENTAL PRODUCTSProtemp PlusK07329601/09/2008
DMG USA, INCLuxatemp UltraK10171009/28/2010
GC America Inc.GC KALOREK08243411/14/2008
GC America Inc.G-Cem AutomixK07328302/20/2008
GC America Inc.MFP-051K12363107/23/2013
    1. Description of Device:
      MSN-006 is a dual-cured, temporary crown and bridge resin. The components consists of Paste A and B, which are filled in a cartridge. Both pastes are automixed with a mixing tip.

  • న్. Indications for Use:

      1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers 2. Fabrication of long-term temporary restorations

  • Technological characteristics: 6.

The technical characteristics are similar (material formulation) but not the same as the predicate devices (Section 10). MSN-006 as compared to Protemp Plus and Luxatemp are two component systems based on resin/composite technology. Bench top testing indicates that even with different formulas, applicant device and predicate devices previously mentioned, meet specifications listed in ISO 10477 (Section 18).

    1. Substantial equivalence:
      The applicant device complies with all the requirements of ISO 10477: 2004 (Dentistry -Polymer-based crown and bridge materials).

The curing mechanism of the new and predicate devices is substantially equivalent in principle. Therefore, the new and predicate devices are the same/similar in function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices.

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In summary, indications for previously mentioned predicate devices and applicant device are the same. Differences in bench top performance tests meet or exceed requirements as outlined in ISO 10477 (Section 18). Data was analyzed utilizing basic statics when comparing to ISO 10477 (Sections 12 and 18).

Differences

The following differences may be noted between the predicate devices and MSN-006:

  • · All products listed under "Performance Test Results" (Table 18) meet ISO 10477 and differences in Flexural Strength, Water Sorption and Solubility are noted.
    1. Packaging

Refills:

  1. EM Cartridge (L) 62.5g (50mL) (1), GC MIXING TIP II SSS (15) 2. EM Cartridge (S) 12.5g (10mL) (1), GC Automix Tip Regular (10) Mixing tip package: 1. GC MIXING TIP II SSS (60) 2. GC Automix Tip Regular (20) Dispenser package: 1. GC CARTRIDGE DISPENSER II (1) 2. GRADIA CORE DISPENSER GUN (1)
    1. Shades A1, A2, A3, A3.5, B1, B3 and BW

10. Shelf Life Evaluation and Storage Conditions:

  • Shelf Life 2 years ।
  • Store in a cool and dark place. 4-25°C (39.2 77.0°F) ।

§ 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.