(225 days)
No
The summary describes a chemical primer for dental materials and does not mention any computational or data-driven processes indicative of AI/ML.
No
The device is described as a primer to increase adhesiveness of dental materials for laboratory procedures, not for treating diseases or conditions.
No
This device is described as a primer to increase adhesiveness of dental materials, with performance studies focused on bond strength and biocompatibility, not diagnosis. Its intended use is for dental laboratory procedures, not for patient diagnosis.
No
The device description clearly states it is a "primer," which is a chemical substance, not software. The performance studies also focus on physical properties like bond strength and biocompatibility, further indicating it is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to increase the adhesiveness of dental materials (composites and acrylic resins) used in dental laboratory procedures. This is a functional purpose related to the physical properties of the materials, not a diagnostic purpose.
- Device Description: The description reinforces that it's a primer for bonding dental materials.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition.
- Performance Studies: The performance studies focus on physical properties like bond strength and biocompatibility, not diagnostic accuracy or clinical outcomes related to a disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is purely related to the physical manipulation and bonding of dental materials in a laboratory setting.
N/A
Intended Use / Indications for Use
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.
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
dental laboratory procedures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Bench Tests: It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes: Appearance, Application characteristics, Refractive index, Bond strength.
Non-Clinical Performance Testing: A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect.
Clinical Performance Testing: No clinical testing has been performed on this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Refractive index: 1.398±0.003
Bond strength: 10MPa
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
November 20, 2018
GC America Inc. Mark Heiss Director, Academic & Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
Re: K180917
Trade/Device Name: GC Acrylic Primer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: August 23, 2018 Received: August 24, 2018
Dear Mark 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 0ate: 2018.11.20
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 - Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K180917
Device Name
GC Acrylic Primer
Indications for Use (Describe)
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
Image /page/3/Picture/1 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color, and there are single quotation marks before and after the letters. The letters are bold and slightly italicized, giving them a dynamic appearance. The background is plain white.
GC AMERICA INC
3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com
-
- Submitter Information: GC America Inc. 3737 W. 127th Street Alsip, IL 60803
| Contact Person:
Phone: | Mark Heiss, D.D.S.
(708) 926-3090 |
|---------------------------|--------------------------------------|
| Alternate Contact: | Lori Rietman |
| Phone: | (708) 926-3092 |
| Fax: | (708) 926-9100 |
| Date Prepared: | April 5, 2018 |
| 2. Device Name: | |
| Proprietary Name: | GC ACRYLIC PRIMER |
| Classification Name: | Resin tooth bonding agent |
| Device Classification: | 21 CFR 872.3200 Class II |
| Product Code: | KLE |
-
- Predicate Devices:
2
- Predicate Devices:
| Product | Applicant | 510(k) No. | Code No | Decision Date | Predicate |
|---|---|---|---|---|---|
| ECLIPSE BONDING AGENT | DENTSPLY International | K051707 | KLE | 06/15/2005 | Primary |
| GRADIA with Composite Primer* | GC America Inc. | K001518 | EBF | 07/05/2000 | Reference |
| G-BOND PLUS (G-aenial Bond) | GC America Inc. | K082768 | KLE | 10/21/2008 | Reference |
| UNIFAST LC | GC America Inc. | K890829 | EBG | 04/17/1989 | Reference |
*GRADIA kit that includes Composite Primer
4. Description of Device:
GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.
5. Packaging
GC Acrylic Primer Package:
- Bottle 6mL
6. Shelf Life
Shelf Life and Storage Conditions:
- Shelf Life 2 years
- Recommended for optimal performance, store in a cool and dark place. 4-25°C (39.2 77.0°F)
-
- Indications for Use:
Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
4
8. Performance Bench Tests:
It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:
- . Appearance
- Application characteristics ●
- Refractive index
- Bond strength .
9. Non-Clinical Performance Testing:
A biocompatibility assessment was completed according to ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Based on the criteria of the protocol and the ISO 10993-5 guidelines, the test article meets the requirements of the test and is not considered to have a cytotoxic effect.
| Property | Requirements |
|---|---|
| Appearance | No contamination of foreign matter. |
| Application characteristics | |
| (coating properties) | Equivalent to reference standard. |
| Refractive index | 1.398±0.003 |
| Bond strength | 10MPa |