(80 days)
Not Found
No
The device description and performance studies focus on the material properties of a silicone impression material, with no mention of AI or ML.
No
The device is a silicone impression material used to check the fit of dental prosthetics by detecting high spots and pressure points, not to treat a condition or disease.
No
The device is a material (silicone impression material) used to check the fit of dental prosthetics by detecting high spots and pressure points, not to diagnose a condition or disease.
No
The device description clearly states it is a silicone impression material, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Checking fit of crowns, bridges, veneers, inlays and dentures." This involves analyzing a sample (the impression material after being used to check the fit) to provide information about the fit of a dental restoration.
- Device Description: The device is a "silicone impression material intended to check fit by detecting the high spots and pressure points." This material is used outside the body to create an impression that is then analyzed.
- Nature of the Test: The process involves taking an impression of the internal surface of a dental restoration and the prepared tooth/tissue, and then examining the impression material to identify areas of pressure or poor fit. This is a diagnostic process performed in vitro (outside the living body).
While the device description focuses on the material properties and how it works, the core function is to provide diagnostic information about the fit of a dental restoration by analyzing the impression material. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.
Checking fit of crowns, bridges, veneers, inlays and dentures.
Product codes
ELW
Device Description
GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material.
Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'Lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease. This product reduces your stress during the fit checking process which is usually done repeatedly until a good fit is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The applicant device, Fit Checker Advanced is equivalent to the predicate device, GC Fit Checker II, in its intended use. The applicant device, Fit Checker Advanced, is equivalent to the predicate device, EXA'lence Extra Light Body Regular set in its chemical composition.
Summary of Performance Specifications:
- Detail reproduction: 20 micrometer (GC Fit Checker Advanced), 20 micrometer (GC Fit Checker II). Test method: Detail reproduction measured by the detail reproduction test method in ISO 4823. Requirement: 20 micrometer. Conforms: Yes.
- Elastic recovery: 98.9 – 99.3% (GC Fit Checker Advanced), 98.5 – 99.6% (GC Fit Checker II). Test method: Elastic recovery measured by the Elastic recovery test method in ISO4823. Requirement: >=96.5%. Conforms: Yes.
- Strain in Compression: 4.2 – 4.5% (GC Fit Checker Advanced), 6.1 – 6.5% (GC Fit Checker II). Test method: Strain in compression measured by the Strain in compression test method in ISO 4823. Requirement: 2.0-20%. Conforms: Yes.
As described above, the applicant device, GC Fit Checker Advanced is substantially equivalent to comparative devices, such as GC Fit Checker II and EXA'lence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032289, K043471, K041398, K973343
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Section 6 - 510(k) Summary
Submitter Information: 1.
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 897-4042 |
| Fax: | (708) 897-4031 |
March 24, 2010 Date Prepared:
Device Name: 2.
| Proprietary Name: | GC Fit Checker Advanced |
|---|---|
| Classification Name: | Dental Impression material |
| Device Classification: | 872.3660 |
| Product Code: | ELW |
Substantial equivalence for the medical device is based on comparison to the following devices:
| Product | Applicant | 510(k) No. | Code No. |
|---|---|---|---|
| Fit Checker II | GC AMERICA, INC | K032289 | ELW |
| GC Fusion Fast (Exa'lence)* | GC AMERICA, INC | K043471 | ELW |
| GC Fusion (Exa'lence)* | GC AMERICA, INC | K041398 | ELW |
| HYDROFLEX | GC AMERICA, INC | K973343 | ELW |
- Due to trademark issues, product was renamed Exa'lence from Fusion/Senn. FDA notified August 18, 2009.
-
- Device description and Intended Use
GC Fit Checker Advanced is a silicone impression material intended to check fit by detecting the high spots and pressure points of crowns, bridges, veneers, inlays and dentures.
- Device description and Intended Use
-
- Components and Mode of Action
GC Fit Checker Advanced has two types of packaging/delivery systems in which the base silicone paste and the catalyst silicone are filled. One is in tubes and the other is a cartidge device, similar to silicone impression material.
- Components and Mode of Action
Fit Checker Advanced was developed combining the technology of Fit Checker and vinyl polyether silicone impression material, EXA'Lence, to achieve higher hydrophilicity. Due to the improved hydrophilicity, the material easily and uniformly spreads and sets sharply under moist oral environment. The optimal translucency enables the users to examine the thickness with ease. This product reduces your stress during the fit checking process which is usually done repeatedly until a good fit is achieved.
1
5. Description of Safety and Substantial Equivalence
The applicant device, Fit Checker Advanced is equivalent to the predicate device, GC Fit Checker II, in its intended use. The applicant device, Fit Checker Advanced, is equivalent to the predicate device, EXA'lence Extra Light Body Regular set in its chemical composition.
5. Performance
1) Summary of Performance Specifications
| Specification | Test method applied | Test results | Requirement | Conforms | ||
|---|---|---|---|---|---|---|
| GC Fit Checker | ||||||
| Advanced | GC Fit | |||||
| Checker II | ||||||
| 1 | Detail | |||||
| reproduction | ||||||
| (μm) | Detail reproduction | |||||
| was measured by the | ||||||
| detail reproduction | ||||||
| test method in ISO | ||||||
| 4823 | 20 | |||||
| 20 | ||||||
| 20 | 20 | |||||
| 20 | ||||||
| 20 | 20μm | Yes | ||||
| 2 | Elastic | |||||
| recovery | ||||||
| (%) | Elastic recovery was | |||||
| measured by the | ||||||
| Elastic recovery test | ||||||
| method in ISO4823 | 98.9 – 99.3 | 98.5 – 99.6 | ≥96.5 | Yes | ||
| 3 | Strain in | |||||
| Compression | ||||||
| (%) | Strain in compression | |||||
| was measured by the | ||||||
| Strain in compression | ||||||
| test method in ISO | ||||||
| 4823 | 4.2 – 4.5 | 6.1 – 6.5 | 2.0-20 | Yes |
As described above, the applicant device, GC Fit Checker Advanced is substantially equivalent to comparative devices, such as GC Fit Checker II and EXA'lence.
4. 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) -
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mark Heiss, DDS Director -Academic and Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
JUN 1 7 2011
Re: K110871
Trade/Device Name: GC Fit Checker Advanced Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: March 24, 2011 Received: March 29, 2011
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony O.m
Chilhony 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 Statement
Indications for Use
11/087 510(k) Number (if known):
Device Name:_GC Fit Checker Advanced
Indications for Use:
Checking fit of crowns, bridges, veneers, inlays and dentures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110871
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