(93 days)
No
The summary describes a dental restorative material and its physical properties and performance tests, with no mention of AI or ML.
No.
The device is a dental restorative material for replacing lost tooth structure, which is a structural or cosmetic purpose rather than a therapeutic one directed at treating disease or dysfunction.
No
The device is described as a "reinforcing dentin replacement material" and a "short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth." Its intended uses are for filling cavities and core build-up. There is no indication that it is used to diagnose any condition; rather, it is a restorative material.
No
The device description clearly states it is a "light cured, short-fiber-reinforced composite for dentin replacement" and is "filled in a syringe," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use of everX Flow clearly indicate it is a material used directly in the mouth for dental restorations (filling cavities, core build-up). It is applied to teeth, not used to test samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The performance studies focus on material properties and biocompatibility, which are relevant to a dental restorative material, not an IVD.
Therefore, everX Flow is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
everX Flow is a reinforcing dentin replacement material suitable for:
- All direct composite restorations including large posterior cavities.
- Deep cavities and endo-treated teeth.
- Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
- Core build-up
Product codes
EBF
Device Description
everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior and anterior teeth
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
No clinical testing has been performed on this device.
Performance testing includes:
- Sensitivity to ambient light
- Depth of cure
- Flexural strength
- Water sorption
- Solubility
- Color stability after irradiation and water sorption
- Radiopacity
The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials).
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
November 22, 2019
GC America Inc. Dr. Mark Heiss Director, Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
Re: K192260
Trade/Device Name: everX Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 20, 2019 Received: August 21, 2019
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| 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) |
|---|
| -------------------------- |
| Device Name | everX Flow |
|---|---|
| Indications for Use (Describe) |
everX Flow is a reinforcing dentin replacement material suitable for:
-
- All direct composite restorations including large posterior cavities.
-
- Deep cavities and endo-treated teeth.
-
- Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
-
- Core build-up
| 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:
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3
Image /page/3/Picture/0 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color, and they appear to be slightly italicized or slanted to the right. There are single quotation marks on either side of the letters.
Image /page/3/Picture/1 description: The image shows a simple, abstract design. On the left side, there's a partial outline of a triangle, depicted in a light teal color. To the right of the triangle, there's a cluster of small, rectangular shapes, also in teal, arranged in a pattern that suggests a scattered or slightly organized grouping. The background is plain white, which makes the teal elements stand out.
510(k) Summary - K192260
| 1. Submitter Information: | GC America Inc. |
|---|---|
| 3737 W. 127th Street | |
| Alsip, IL 60803 | |
| Contact Person: | Mark Heiss, D.D.S. |
| Phone: | (708) 926-3090 |
| Alternate Contact: | Lori Rietman |
| Phone: | (708) 926-3092 |
| Fax: | (708) 925-0373 |
| Date Prepared: | October 28, 2019 |
| 2. Device Name: | |
| Proprietary Name: | everX Flow |
| Classification Name: | Tooth shade resin material |
| Device Classification: | Class II, 872.3690 |
-
- Predicate Devices:
Product Code:
- Predicate Devices:
| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|---|---|---|---|---|---|
| everX Posterior | GC America Inc. | K153127 | EBF | Primary | 05/20/2016 |
| Gradia Core | GC America Inc. | K082171 | EBF | Reference | 10/30/2008 |
| G-aenial Flo X | GC America Inc. | K133182 | EBF | Reference | 4/9/2014 |
4. Description of Device:
everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.
5. Indications for Use:
-
everX Flow is a reinforcing dentin replacement material suitable for: ● All direct composite restorations including large posterior cavities.
EBF -
. Deep cavities and endo-treated teeth.
-
. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
-
. Core build-up
6. Packaging
everX Flo Package:
- i Syringe (3.7 g / 2 mL) QTY: 1
- Dispensing Tip III QTY: 20 -
- Light protective cap QTY: 1 i
-
- Shades
Shades available: Bulk Shade, Dentin Shade
4
-
- Shelf Life and Storage Conditions:
- Shelf Life 3 years ।
- Recommended for optimal performance, store in a cool and dark place (4-25°C / 39.2-77.0°F) away from high temperatures i or direct sunlight.
Performance Bench Tests 9.
It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:
- · Sensitivity to ambient light
- · Depth of cure
- · Flexural strength
- · Water sorption
- · Solubility
- · Color stability after irradiation and water sorption
- · Radiopacity
The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials) (see table below).
| Property | Requirements | |
|---|---|---|
| 1 | Sensitivity to ambient light | Remain physically homogeneous |
| 2 | Depth of cure | Opaque shade: > 1.0 mm |
| Other shade: > 1.5 mm | ||
| 3 | Flexural strength | > 80 MPa |
| 4 | Water sorption |