(204 days)
No
The summary describes a composite resin material and its physical properties, with no mention of AI or ML capabilities.
No.
The device is a fiber-reinforced composite material used for tooth restoration, not a device that provides therapy for a disease or condition.
No
Explanation: The device is described as a fiber-reinforced composite for restoring carious teeth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "light-cured, fiber-reinforced, universal type composite resin packaged in a unitip," which are physical materials and components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "restoration of prepared carious teeth, including large posterior cavities with loss of dentin." This describes a material used directly on the patient for treatment, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description confirms it's a "light-cured, fiber-reinforced, universal type composite resin." This is a material used in dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
Therefore, everX Posterior is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carious teeth, posterior cavities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and the testing results indicate that the device conforms to the required specifications for sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, and color stability after irradiation and water sorption and is therefore suitable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 872.3690 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized design featuring a series of overlapping human profiles, creating a sense of unity and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
GC America Inc. Mark Heiss, D.D.S. Director, Academic & Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
Re: K153127
Trade/Device Name: everX Posterior Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 21, 2016 Received: April 22, 2016
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 - Mark Heiss, D.D.S.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Tina Kiang
-s
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 – Indications for Use Statement
Indications for Use
510(k) Number: K153127
Device Name: everX Posterior
Indications for Use:
everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.
Prescription Use (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)
Page 4.1 of 4.1
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Image /page/3/Picture/1 description: The image shows the text "'GC'" in a stylized, sans-serif font. The text is a teal color, and the letters are slightly italicized. The apostrophes are also teal and are placed at the beginning and end of the text.
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
- Submitter Information:
| Contact Person: | Mark Heiss, D.D.S. |
|---|---|
| Phone: | (708) 926-3090 |
| Alternate Contact: | Lori Rietman |
| Phone: | (708) 926-3092 |
| Fax: | (708) 926-9100 |
Date Prepared: April 21, 2016
-
- Device Name:
| 510(k) Number: | K153127 |
|---|---|
| Proprietary Name: | everX Posterior |
| Classification Name: | Tooth shade resin material |
| Device Classification: | Class II, 872.3690 |
| Product Code: | EBF |
-
- Predicate Devices:
| Product | Applicant | Submission | Procode | |
|---|---|---|---|---|
| Primary | Build-It Total Core | Sybron Dental Specialties, | ||
| Inc. | K102703 | EBF | ||
| Reference | G-aenial Sculpt | |||
| (MFP-051) | GC America Inc. | K123631 | EBF |
4. Description of Device:
everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.
- న్. Indications for Use:
everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.
Technological characteristics: 6.
The applicant device is composed of randomly oriented short E-glass and inorganic particulate fillers in combination with a semi-interpenetrating polymer network matrix that consists of bisphenol A glysidyl methacrylate, triethyleneglycol dimethacrylate and polymethylmethacrylate. The glass fibers are pre-impregnated into the composite resin and are 0.8 mm average length.
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| Applicant device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade name | everX Posterior | Build-It Total Core | G-ænial Sculpt (MFP-051) |
| Manufacturer | GC Corporation | Sybron Dental Specialties | GC Corporation |
| Indications | |||
| for Use | everX Posterior is indicated for | ||
| use as a fiber reinforced | |||
| composite for the restoration of | |||
| prepared carious teeth, including | |||
| large posterior cavities with loss | |||
| of dentin. | Build-it Total Core is indicated for | ||
| use as |
- Core build up material on vital
and non-vital teeth - Sealing root canal openings,
- Cavity floor liner,
- Post cementation,
- Restorative material
- Dentin replacement material. | 1. Direct restorative for class I,
II, III, IV, V cavities. - Direct restorative for
wedge-shaped defects and root
surface cavities. - Direct restorative for veneers
and diastema closure. |
| Product
description | everX Posterior is a
fiber-reinforced, universal shade
composite resin paste filled in a
unitip suitable as a reinforcing
material for direct composite
restorations, especially in large
posterior cavities.
Physical properties are within the
acceptable range for flexural
strength, depth of cure, water
sorption, solubility in accordance
with ISO 4049:2009 Dentistry -
Polymer based restorative materials | Build-it Total Core is a two
component, catalyst and base, fiber
reinforced, self-adhesive composite
that contains fluoride, and is
available in esthetic and contrast
shades
Physical properties tested include
flexural strength, compressive
strength, water solubility, water
absorption | G-aenial Sculpt is a light cured
nano-filled radiopaque
composite resin filled in a
syringe and unitip and
available in several shades.
The device is used for the
restorations of both anterior
and posterior teeth.
Physical properties tested
In accordance with ISO
4049:2009 Dentistry - Polymer
based restorative materials |
| Mode of action | The paste material with glass
fibers contains a
photo initiator to allow for
polymerization through light
curing resulting in a solid
material for dental
restorations. | The two component paste material
uses dual cure to become a
solid material for dental
restorations | G-aenial Sculpt is a paste
composite reinforced by a
dispersion of filler particles
bonded to the resin matrix with a
photo initiator to allow for
curing/conversion. The end result
is a conversion from a paste to a
solid material for dental
restorations. |
7. Non clinical performance testing
Bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and the testing results indicate that the device conforms to the required specifications for sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, and color stability after irradiation and water sorption and is therefore suitable for the intended use.
8. Biocompatibility
Biocompatibility assessment was based upon ISO 10993-1 and testing included cytotoxicity in accordance with ISO 10993-5, and sensitization and irritation in accordance with ISO 10993-10.
Substantial equivalence: 9.
everX Posterior is similar to the primary predicate (K102703) Build-It Total Core in that both are fiber
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reinforced composite material used for dental restorations; both devices make use of pre-impregnated glass fibers to provide support to the composite mix for their intended use: both devices are indicated for use in large cavities with loss of dentin including posterior teeth, tooth core structure replacement or build up. The predicate device is not indicated for use as a root canal sealer and cavity liner because it is not self-adhesive meaning like the predicate K102703. A technologic difference between the applicant device and primary predicate device is that the applicant device is a light cured paste with a photo initiator, while the predicate device K102703 is a dual cure, two paste system of catalyst and base, and that contains fluoride. In principle, the curing mechanism of the applicant and predicate devices is substantially equivalent in principle as they both undergo polymerization to become a solid material adapted to a cavitation in a tooth to become a dental restoration.
everX Posterior and the reference predicate G-aenial Sculpt (K123631) are both light cured composite resins intended to be used as dental restorative materials: the device formulations are identical for all components, except that the applicant device also includes glass fibers and polymethylmethacrylate. everX Posterior is available only in universal shade whereas both of the predicates are available in a range of shades.
All three devices have been tested for physical properties including flexural strength, water sorption, depth of cure. The results of testing the physical properties of the applicant device in accordance with the FDA recognized standard for polymer based restorative materials used in dentistry, demonstrate that the applicant device is similar to the predicate devices in function and intended use.
10. Conclusion
Given the similarities in intended use, mode of action, and chemical composition, and in consideration of the results of non-clinical performance testing and biocompatibility testing, everX Posterior is substantially equivalent to the predicate and reference devices.
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