(152 days)
- Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
- Cementation of metal, ceramic, fiber posts, and cast post and cores.
GAM-200 is a dual-cured self-adhesive resin cement. The mixed cement is hardened through the polymerization activated by redox or photo initiator system. The adhesiveness to tooth structure develops with phosphoric ester monomers which form ionic bonds with calcium ions. The acidic monomers also can polymerize with frame-forming monomers. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip and directly applied to restorations or the prepared cavity.
The provided text describes a 510(k) premarket notification for a dental cement device, GAM-200. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through clinical studies that would involve acceptance criteria and performance metrics in the way a medical AI/CAD device would.
Therefore, the information requested in your prompt (e.g., acceptance criteria, sample size for test/training set, number of experts, adjudication methods, MRMC study, standalone performance, ground truth types) is not applicable to this type of device and submission.
The document discusses the technical characteristics and equivalence of the GAM-200 dental cement to predicate devices based on material properties and in vitro tests, not on clinical performance in diagnosing or assisting with interpretation in a human-in-the-loop setting.
However, I can extract the relevant information that is present in the document related to how the device's characteristics were assessed against established standards and predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (compared to) | Reported Device Performance (GAM-200) |
|---|---|---|
| Curing Mechanism | Same as predicate devices (polymerization of uncured methacrylate ester monomers, redox or photo initiator system). | Same as predicate devices (polymerization activated by redox or photo initiator system). |
| Adhesive Mechanism | Same as predicate devices (acidic ester monomer developing adhesiveness to tooth structures by forming ionic bonds with calcium ions). | Same as predicate devices (phosphoric ester monomers forming ionic bonds with calcium ions; acidic monomers polymerize with frame-forming monomers). |
| Setting Time | Within the same range as comparative (predicate) devices. | In the same range as comparative devices. |
| Depth of Cure | Equivalent to comparative (predicate) devices. | Equivalent to comparative devices. |
| Flexural Strength | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Water Sorption | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Solubility | Values indicating stability of materials in oral environment, equivalent to predicate devices. | Equivalent values to predicate devices. |
| Biological Evaluation (Cytotoxicity) | Equivalent to predicate devices (tested in accordance with MTT Assay method). | Equivalent to predicate devices. |
| ISO 4049: 2009 | Compliance with all requirements for Dentistry Polymer-based restorative materials. | Complies with all requirements. |
| ISO 11405: 2003 (Bond Strengths) | Equivalent bond strengths to predicate devices (in accordance with the standard). | Equivalent bond strengths to predicate devices. |
2. Sample size used for the test set and the data provenance: Not applicable. The evaluations are primarily in vitro material science tests against standards and predicate devices, not clinical trials with human subjects.
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 material properties is established through standardized testing procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 a dental cement, not an AI/CAD system for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is based on established international standards (ISO 4049: 2009, ISO 11405: 2003) and laboratory test results for material properties and biological evaluation (cytotoxicity via MTT Assay). The comparison is against the performance of legally marketed predicate devices.
8. The sample size for the training set: Not applicable. There is no machine learning "training set" for this device.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
KI20243
JUN 2 7 2012
Section 6 - 510(k) Summary
-
- Submitter Information:
GC AMERICA INC.
3737 W. 127" Street Alsip, IL 60803
- Submitter Information:
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 926-3090 |
| Fax: | (708) 597-6222 |
Date Prepared: January 23, 2012
-
- Device Name:
| Proprietary Name: | GAM-200 |
|---|---|
| Classification Name: | Dental Cement |
| Device Classification: | Class II, 872.3275 |
| Product Code: | EMA |
3. Predicate Devices:
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| GC America Inc. | G-CEM Automix (GAM-100) | K073283 | 02/20/2008 |
| KERR CORPORATION | Maxcem Elite (Maxcem 2) | K073209 | 01/29/2008 |
4. Description of Device:
GAM-200 is a dual-cured self-adhesive resin cement. The mixed cement is hardened through the polymerization activated by redox or photo initiator system. The adhesiveness to tooth structure develops with phosphoric ester monomers which form ionic bonds with calcium ions. The acidic monomers also can polymerize with frame-forming monomers.
The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip and directly applied to restorations or the prepared cavity.
న్. Indications for Use:
- Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
-
- Cementation of metal, ceramic, fiber posts, and cast post and cores.
6. Technological characteristics:
The curing mechanism of the predicates is polymerization of uncured methacrylate ester monomers. This reaction is caused by redox or photo initiator system. These devices contain an acidic ester monomer which develops adhesiveness to tooth structures. The applicant device also has a same curing and adhesive mechanism.
Page 6.1 of 6.2
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The setting time of GAM-200 comes in the same range of the comparative devices and the depth of cure is equivalent. These indicate the proper setting property of the applicant for clinical use. The applicant device also shows equivalent values in flexural strength, water sorption and solubility, which indicate the stability of materials in oral environment.
7. Substantial equivalence:
The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry Polymer-based restorative materials). The bond strengths of the applicant in accordance with ISO 11405: 2003 are equivalent to the predicate devices. In terms of the biological evaluation, the cytotoxicity test in accordance with MTT Assay method showed that the applicant device . is equivalent to the predicates.
8. Conclusion:
Thus, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the applicant device is substantially equivalent to the predicate devices.
Page 6.2 of 6.2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 27 2022
Mr. Mark Heiss Director, Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K120243
Trade/Device Name: GAM-200 Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: May 9, 2012 Received: May 10, 2012
Dear Mr. 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- Mr. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.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 yours,
hn foc
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
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Section 5
Indications for Use
510(k) Number (if known):
Device Name: GAM-200
Indications for Use:
-
Cementation of all types of all ceramic, resin and metal-based inlays, crowns and bridges.
-
Cementation of metal, ceramic, fiber posts, and cast post and cores.
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)
Nh
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120243
Page 5.1 of 5.1
§ 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.