(152 days)
No
The device description focuses on the chemical composition and physical properties of a resin cement, with no mention of AI or ML. The performance studies evaluate material properties and bond strength, not algorithmic performance.
No.
The device is a resin cement used for cementation of dental restorations and posts, which falls under restorative dentistry and not therapeutic treatment for a disease or condition.
No
Explanation: The device is a dental cement used for the cementation of various dental restorations. Its described function is to bond materials, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical material (resin cement) and its chemical properties and application method, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cementation of dental restorations (inlays, onlays, crowns, bridges, posts, and cores). This is a direct clinical application within the mouth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a self-adhesive resin cement used for bonding dental materials. This aligns with a dental restorative material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the cement (setting time, depth of cure, flexural strength, bond strength) and biological compatibility (cytotoxicity), which are relevant to a dental material's performance and safety in the oral environment. These are not diagnostic performance metrics.
In summary, the device is a dental material used for bonding restorations, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
EMA
Device Description
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
1
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
2
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.
3
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
4
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