(198 days)
No
The device description focuses on the material composition and physical properties of a dental restorative material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests and biocompatibility assessments, not studies evaluating algorithmic performance.
No
Explanation: The device is a temporary restorative material for dental use, specifically a pit & fissure sealant, root surface sealant, or temporary filling. Its purpose is to protect and fill, not to provide therapy or treatment for a disease. While it addresses hypersensitivity and protects immature enamel, these actions are more preventative or protective than therapeutic in the sense of actively treating a pathology.
No
The device description indicates it is a "bioactive glass ionomer for temporary restorative material" and its intended uses include "Pit & Fissure Sealant," "Hypersensitivity," "Protection immature enamel," and "Temporary filling." These are all therapeutic or restorative functions, not diagnostic ones.
No
The device description clearly states it is a "bioactive glass ionomer for temporary restorative material" consisting of "powder and liquid filled in a capsule" and applied with a "capsule applier." This describes a physical material and associated hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the tooth (sealing, filling, protection, treating hypersensitivity). These are therapeutic or protective applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a "bioactive glass ionomer for temporary restorative material." This is a material applied to the tooth, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
In Vitro Diagnostics are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
- Pit & Fissure Sealant and Root Surface Sealant
- Hypersensitivity due to abrasion and early non-cavitated lesions
- Protection immature enamel
- Temporary filling including endodontic access
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.
GC Fuji Triage EP Package: Capsule (Powder 0.30g/Liquid 0.15g) - QTY: 50
Shades available: Pink, White
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth (enamel, dentin)
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)
Performance Bench Tests:
It is confirmed that the device conforms to the required specifications of ISO 9917-1:2007.
Non-Clinical Performance Testing:
A biocompatibility assessment was completed according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- Cytotoxicity (L929 MEM Elution Test) - Based on the criteria of the protocol of ISO 10993-5
- Sensitivity (Kligman Maximization Test) - Based on the criteria of the protocol of ISO 10993-10
- Irritation (Intracutaneous Injection Test) - Based on the criteria of the protocol of ISO 10993-10
In conclusion, biocompatibility of GC Fuji Triage EP is acceptable device from the biological evaluation result.
It is confirmed that the device conforms to the required specifications of ISO 9917-1: 2007 Dentistry -Water-based cements - Part 1: Powder/liquid acid-base cements and company standard is suitable for its intended use. Performance testing includes for the following properties:
- Net setting time: 1.5 to 6 min
- Compressive strength: More than 100 MPa
- Acid erosion: Less than 0.17 mm
- Optical properties (opacity): 0.35 to 0.90
- Optical properties (color): Match the nominated shade guide
- Acid-soluble lead content: Less than 100mg/kg
- Radiopacity: More than equivalent thickness of aluminum
Clinical Performance Testing:
No clinical testing has been performed on this device.
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
§ 872.3275 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2020
GC America Inc. Mark Heiss Director, Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60780-3
Re: K193484
Trade/Device Name: GC Fuji Triage EP Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: June 2, 2020 Received: June 5, 2020
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 "Nandu" Nandkumar, Ph.D. 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 GC Fuji Triage EP
Indications for Use (Describe)
-
Pit & Fissure Sealant and Root Surface Sealant
-
Hypersensitivity due to abrasion and early non-cavitated lesions
-
Protection immature enamel
-
Temporary filling including endodontic access
Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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FORM FDA 3881 (7/17)
Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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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 appear to be slightly italicized or slanted to the right. There are single quotation marks on either side of the letters.
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510(k) Summary 1
| Submitter Information:
GC America Inc.
3737 W. 127th Street
| Alsip, IL 60803 | |
|---|---|
| Contact Person: | |
| Phone: | |
| Alternate Contact: | |
| Phone: | |
| Fax: | Mark Heiss, D.D.S. |
| (708) 926-3090 | |
| Lori Rietman | |
| (708) 926-3092 | |
| (708) 925-0373 | |
| Date Prepared: | June 30, 2020 |
| 1. Device Name: | |
| Proprietary Name: | |
| Classification Name: | |
| Device Classification: | GC Fuji Triage EP |
| Conventional Glass Ionomer Cement | |
| Class II, 872.3275 |
EMA
-
- Predicate Devices:
Product Code:
- Predicate Devices:
| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|---|---|---|---|---|---|
| GC Fuji Triage | GC America Inc. | K013198 | EMA | Primary | 10/29/2001 |
| MI VARNISH | GC America Inc. | K102808 | LBH | Reference | 12/22/2010 |
-
- Description of Device:
GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.
- Description of Device:
GC Fuji Triage EP Package: Capsule (Powder 0.30g/Liquid 0.15g) - QTY: 50
Shades available: Pink, White
Shelf Life and Storage Conditions:
- Shelf Life 2 years -
- -Recommended for optimal performance, store in a cool and dark place. 4-25℃ (39 - 77°F)
-
- Performance Bench Tests:
It is confirmed that the device conforms to the required specifications of ISO 9917-1:2007.
న్. Non-Clinical Performance Testing:
A biocompatibility assessment was completed according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
4
Cytotoxicity (L929 MEM Elution Test)
Based on the criteria of the protocol of ISO 10993-5
Sensitivity (Kligman Maximization Test)
Based on the criteria of the protocol of ISO 10993-10
Irritation (Intracutaneous Injection Test)
Based on the criteria of the protocol of ISO 10993-10
GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative and does come in contact with body tissues (tooth - enamel, dentin) for more than 30 days
In conclusion, biocompatibility of GC Fuji Triage EP is acceptable device from the biological evaluation result.
It is confirmed that the device conforms to the required specifications of ISO 9917-1: 2007 Dentistry -Water-based cements - Part 1: Powder/liquid acid-base cements and company standard is suitable for its intended use. Performance testing includes:
| Property | Requirements | |
|---|---|---|
| 1 | Net setting time | 1.5 to 6 min |
| 2 | Compressive strength | More than 100 MPa |
| 3 | Acid erosion | Less than 0.17 mm |
| 4 | Optical properties (opacity) | 0.35 to 0.90 |
| 5 | Optical properties (color) | Match the nominated shade guide |
| 6 | Acid-soluble lead content | Less than 100mg/kg |
| 7 | Radiopacity | More than equivalent thickness of aluminum |
6. Clinical Performance Testing
No clinical testing has been performed on this device.
7. Comparison of Technology:
The hardening mechanism of GC Fuji Triage EP and GC Fuji Triage are substantially equivalent in principle. Thus, the applicant device and the predicate device are the same in function and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.
The following differences may be noted between GC Fuji Triage EP and the predicate devices:
- GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide amorphous calcium phosphate) in ● the formulation.
- GC Fuji Triage EP includes the elongation tip.
- The applicant device, Fuji Triage EP, is a glass ionomer cement while MI VARNISH is a topical fluoride varnish.
8. Conclusion
The applicant device, GC Fuji Triage EP, is substantially equivalent in qualitative features to the comparative device, FUJI Triage.
5
| Applicant Device | Primary Device | Reference Device | |
|---|---|---|---|
| GC Fuji Triage EP | FUJI Triage | ||
| K013198 | MI VARNISH | ||
| K102808 | |||
| Trade name | GC Fuji Triage EP | FUJI Triage | |
| K013198 | MI VARNISH | ||
| K102808 | |||
| Manufacturer | GC Corporation | GC Corporation | GC Corporation |
| Product | |||
| category | Restorative glass ionomer cement | Restorative glass ionomer cement | Topical fluoride varnish |
| Powder/Liquid | |||
| ratio | Powder 0.30g/Liquid 0.15g | Powder 0.30g/Liquid 0.15g | Not applicable |
| Indications for | |||
| Use | 1. Pit & Fissure Sealant and Root Surface Sealant |
- Hypersensitivity due to abrasion and early non-
cavitated lesions - Protection immature enamel
- Temporary filling including endodontic access | 1. Pit and fissure sealant.
- Treatment of early non-cavitated lesions; such
as tooth brush abrasion and root surface
sensitivity - Intermediate restorative material
- Temporary filling of endodontic access. | Treatment of hypersensitive teeth. |
| Product
description | The Device consists of powder and liquid and filled in a
capsule. The mixed cement sets by acid-base reaction of
fluoro-alumino-silicate glass and polyacrylic acid. | The device consists of powder and liquid and
filled in a capsule. The mixed cement sets by
acid-base reaction of fluoro-alumino-silicate
glass and polyacrylic acid. | The device is a 5% sodium fluoride
varnish that a desensitizing action
when applied to tooth surfaces. The
application leaves a film of varnish on
tooth surfaces. |
| Technological
Characteristics
and Mode of
action | GC Fuji Triage EP contains CPP-ACP (casein
phosphopeptide - amorphous calcium phosphate).
CPP-ACP was added to moderate the strength of
cement for the use as more temporary or provisional
restoration material. CPP-ACP was chosen as the
additive for regulating the strength because it does not
inhibit the setting reaction of the material while can tone
down the physical strength.
Aluminum ion, Strontium ion and Fluoride ion are
released from Fluoro-alumino-silicate glass due to this
reaction. Of these ions, Aluminum ion and Strontium ion
crosslink the polyacrylic acid and form hydrogel.
Fluoride ion doesn't react, it remains inside hydrogel as
ion. This material set by the above reaction. The set
material contains fluoride ion inside as free ion. These
ions can be gradually release from the setting material
in very small amounts with time. | GC Fuji Triage Capsule is radiopaque glass
ionomer protection and temporary restorative
material in capsules consisting of powder and
liquid. The powder is Fluoro-alumino-silicate
glass and liquid is Polyacrylic acid solution.
They are mixed with an electrical capsule mixer
and applied directly to a cavity with a capsule
applier. Aluminum ion, Strontium ion and
Fluoride ion are released from Fluoro-alumino-
silicate glass due to this reaction. Of these ions,
Aluminum ion and Strontium ion crosslink the
polyacrylic acid and form hydrogel. Fluoride ion
doesn't react, it remains inside hydrogel as ion.
This material set by the above reaction. The set
material contains fluoride ion inside as free ion.
These ions can be gradually release from the
setting material in very small amounts with time. | MI Varnish is a paste formula
delivered in unit dose package. The
laminating film lid is peeled off and
the paste is applied on the tooth
surface with a disposable brush. The
device is a 5% sodium fluoride
varnish and also contains CPP-ACP
(casein phosphopeptide -
amorphous calcium phosphate) in
the formula. When the device is
applied on the tooth surface, a thin
film of varnish is left on the tooth
surface by evaporation of ethanol on
tooth. The film is composed by
polyvinyl acetate as film former and
hydrogenated rosin as adhesives.
The film works for desensitizing of
the tooth surface. |