(237 days)
No
The document describes a dental restorative material and its dispensing mechanism, with no mention of AI or ML capabilities.
No
The device is a restorative material used for dental fillings, not a therapeutic device designed to treat a disease or condition.
No
Explanation: The device description indicates that GC Fuji Direct is a restorative material used for fillings and core build-ups, not for diagnosing medical conditions. Its intended uses are to restore teeth, not to identify diseases or conditions.
No
The device description clearly states it is a light-cured resin-modified restorative glass ionomer cement consisting of two pastes, a dispenser, and a mixing tip. 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 for dental restorations, core build-up, and as a base material. These are all procedures performed directly on the patient's tooth.
- Device Description: The device is a restorative material applied to the tooth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for restorative purposes.
N/A
Intended Use / Indications for Use
-
- Class III and V restorations
-
- Restoration of primary teeth
-
- Core build-up
-
- Cases where radiopacity is required
-
- Base material for Class I and Class II cavities using a sandwich laminate technique.
Product codes (comma separated list FDA assigned to the subject device)
EMA, EBF
Device Description
GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.
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
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 9917-2:2010.
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.
Cytotoxicity (L929 MEM Elution Test) Based on the criteria of the protocol of ISO 10993-5
Sensitivitv (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 Direct is acceptable device from the biological evaluation result.
It is confirmed that the device conforms to the required specifications of ISO 9917-2: 2010 (Dentistry -Water-based cements -Part2: Resin-modified cements) and company standard is suitable for its intended use. Performance testing includes:
Property: Appearance; Requirements: No visible sign of extraneous matter, Free of any gelation
Property: Working time; Requirements: The indenter shall make a complete circular indentation.
Property: Setting time; Requirements: The indenter shall fail to make a complete circular indentation.
Property: Flexural strength; Requirements: More than 25 MPa
Property: Radiopacity; Requirements: More than equivalent thickness of aluminum
Property: Shade and color stability; Requirements: Shade: Shall match with the manufacture's nominated shade guide, Color stability: No significant change from the reference specimen
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA text is in a blue sans-serif font.
GC America Inc. Mark Heiss Director, Regulatory Affairs 3737 W. 127th Street Alsip. Illinois 60803
Re: K172382
Trade/Device Name: GC Fuji Direct Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, EBF Dated: February 27, 2018 Received: February 28, 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. 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.
April 2, 2018
1
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 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.
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.
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/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.
Mary S. Runner -S
Tina 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
Indications for Use
510(k) Number (if known) K172382
Device Name GC Fuji Direct
Indications for Use (Describe)
-
- Class III and V restorations
-
- Restoration of primary teeth
- Core build-up
-
- Cases where radiopacity is required
- Base material for Class I and Class II cavities using a sandwich laminate technique.
| 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)
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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 appear to be slightly italicized. There are single quotation marks before and after the letters. The background is 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: | Mark Heiss, D.D.S | |
|---|---|---|
| Phone: | (708) 926-3090 | |
| Alternate Contact: | Lori Rietman | |
| Phone: | (708) 926-3092 | |
| Fax: | (708) 926-9100 | |
| Date Prepared: | March 26, 2018 | |
| 2. | Device Name: | |
| Proprietary Name: | GC Fuji Direct | |
| Classification Name: | Dental Cement | |
| Device Classification: | Class II, 872.3275 | |
| Product Code: | EMA |
-
- Predicate Devices:
| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|---|---|---|---|---|---|
| GC FUJI FILLING LC | GC America Inc. | K051427 | EMA | Primary | 08/22/2005 |
| GC Fuji II LC Capsule | GC America Inc. | K993973 | EMA | Reference | 01/11/2000 |
| GC FUJICEM 2 | GC America Inc. | K001730 | EMA | Reference | 07/17/2000 |
| GC Kalore | GC America Inc. | K082434 | EBF | Reference | 11/14/2008 |
4. Description of Device:
GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.
GC Fuji Direct Package:
- Paste Pak Cartridge (14.9 g / 7.2 mL) (1) -
- -GC Fuji Direct Mixing Tip (20)
- Paste Pak Dispenser II (1) -
Shades available:
A1, A2, A3
Shelf Life and Storage Conditions:
- Shelf Life 2 years -
- -Recommended for optimal performance, store in a cool and dark place. 4-25℃ (39.2 - 77.0ºF)
4
- న. Indications for Use:
-
- Class III and V restorations
-
- Restoration of primary teeth
-
- Core Build-up
-
- Cases where radiopacity is required
-
5 Base material for Class 1 and Class II cavities using a sandwich laminate technique
-
- Performance Bench Tests:
It is confirmed that the device conforms to the required specifications of ISO 9917-2:2010.
- Performance Bench Tests:
-
- 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.
- Non Clinical Performance Testing:
Cytotoxicity (L929 MEM Elution Test)
Based on the criteria of the protocol of ISO 10993-5
Sensitivitv (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 Direct is a light-cured resin-modified restorative glass ionomer cement and does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours.
In conclusion, biocompatibility of GC Fuji Direct is acceptable device from the biological evaluation result.
It is confirmed that the device conforms to the required specifications of ISO 9917-2: 2010 (Dentistry -Water-based cements -Part2: Resin-modified cements) and company standard is suitable for its intended use. Performance testing includes:
| Property | Requirements |
|---|---|
| Appearance | *No visible sign of extraneous matter |
| *Free of any gelation | |
| Working time | The indenter shall make a complete circular indentation. |
| Setting time | The indenter shall fail to make a complete circular indentation. |
| Flexural strength | More than 25 MPa |
| Radiopacity | More than equivalent thickness of aluminum |
| Shade and color stability | *Shade: Shall match with the manufacture's nominated shade guide |
| *Color stability: No significant change from the reference specimen |
8. Clinical Performance Testing
No clinical testing has been performed on this device.
5
| Table 5.1 | |||||
|---|---|---|---|---|---|
| Applicant device | Primary Device | Reference Device | Reference Device | Reference Device | |
| Trade name | GC Fuji Direct | ||||
| K172382 | GC FUJI FILLING LC | ||||
| K051427 | GC Fuji II LC Capsule | ||||
| K993973 | GC FujiCEM 2 | ||||
| K001730 | GC Kalore | ||||
| K082434 | |||||
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Product | |||||
| category | Resin-modified glass | ||||
| ionomer cement | Resin-modified glass | ||||
| ionomer cement | Resin-modified glass ionomer | ||||
| cement | Radiopaque reinforced | ||||
| glass ionomer Luting | |||||
| cement | Light-cured composite | ||||
| restorative | |||||
| Paste/Paste | |||||
| ratio | |||||
| Or | |||||
| Powder/Liquid | |||||
| ratio | Paste A / Paste B = 1.6 / 1.0 | ||||
| (w/w) | Paste A / Paste B = 3.3 / 1.0 | ||||
| (w/w) | Powder / Liquid = 3.3 / 1.0 | ||||
| (w/w) | Paste A / Paste B = 2.0 / 1.0 | ||||
| (w/w) | (1-paste) | ||||
| Indications for | |||||
| Use | 1. Class III and V restorations |
- Restoration of primary teeth
- Core Build-up
- Cases where radiopacity is
required
5 Base material for Class 1
and Class II cavities using a
sandwich laminate technique | 1. Class III and V
restorations, particularly for
cervical erosions and root
surface caries - Restoration of primary
teeth - Core build up
- Cases where radiopacity is
required - As a base or a liner | 1. Class III and V restoration;
particularly areas
of cervical erosion,
abfraction lesions and
root surface caries - Restoration of primary teeth
- As a base of liner
- Core build-ups/block-outs
(particularly of vital teeth) - Cases in which a
radiopaque restoration is
required | 1. Cementation of
metal-based inlays, onlays,
crowns and bridges - Cementation of resin
inlays, onlays, crowns and
bridges - Cementation of all
ceramic inlays - Cementation of high
strength (zirconia based) all
ceramic crowns and bridges - Cementation of metal,
ceramic and fiber posts | 1. Direct restorative for
Class III, IV, V cavities. - Direct restorative for
wedge-shaped defects
and root surface
cavities. - Direct restorative for
veneers and diastema
closure. - Direct restorative for
Class I and II cavities. |
| Product
description | The device consists of 2
pastes filled in cartridges.
Paste A and B are
automixed with an automix
tip and directly applied to the
prepared cavity.
The bioactive material sets
by acid-base reaction of
fluoroalumino-silicate glass
and Polyacrylic acid, and
polymerization of
methacrylate monomers. | The device consists of 2
pastes filled in cartridges.
Paste A and B are mixed and
directly applied to the
prepared cavity.
The material sets by
acid-base reaction of
fluoroalumino-silicate glass
and Polyacrylic acid, and
polymerization of
methacrylate monomers. | The device consists of powder
and liquid filled in a capsule.
Powder & liquid are mixed with
electric capsule mixers. The
mixed material is directly
applied to a prepared cavity
using a capsule applier.
The material sets by acid-base
reaction of
fluoroalumino-silicate glass
and Polyacrylic acid, and
polymerization of
methacrylate monomers. | The device consists of 2
pastes filled in a Paste Pak
Cartridge. The material is
dispensed with GC Paste
Pak Dispenser and
hand-mixed. Optionally GC
FujiCEM Mixing Tip is
available for automixing
while pastes dispensation. | The device is a
light-cured micro-filled
radiopaque composite
resin for the restoration
of both anterior and
posterior teeth. The
device consists of two
delivery systems,
Unitip and Syringes.
The system is
available in a variety of
shades. |
| Table 5.1 (Continued) | | | | | |
| Instruction for
use | 1. Tooth preparation - Mix of 2 pastes
- Application to cavity
- Finishing | 1. Tooth preparation
- Mix of 2 pastes
- Application to cavity
- Finishing | 1. Tooth preparation
- Mix of powder and liquid
- Application to cavity
- Finishing | 1. Tooth preparation
- Restoration
preparation - Mix of 2 pastes
- Cementation | 1. Tooth Preparation
- Bonding Treatment
- Placement of GC KALORE
- Contouring before Light Curing
- Light Curing
- Finishing and Polishing |
| Light curing
specification | Light cure using a light curing
unit.
10 sec. (High Power LED Light)
(>1200mW/cm2)
20 sec. (Halogen/LED) (700
mW/cm2) | Light cure the material with a
visible light curing device.
In the case of G-Light,
light-cure for 20 seconds. | Light-cure for 20 seconds
using a suitable visible light
curing device (470nm
wavelength) | | Light cure GC KALORE using
a light curing unit.
In the case of High power
LED (more than
1200mW/cm2) light-cure for
10 seconds.
In the case of Halogen / LED
(700mW/cm2) light-cure for
20 seconds. |
| Technological
Characteristics
and Mode of
action | The device is set by acid-base
reaction and polymerization
after mixing 2 pastes.
Acid-base reaction occurs
Fluoroalumino-silicate glass in
Paste A!and Polyacrylic acid in
Paste B. | The device is set by acid-base
reaction and polymerization
after mixing 2 pastes.
Acid-base reaction occurs
Fluoroalumino-silicate glass in
Paste A!and Polyacrylic acid in
Paste B. | The device is set by
acid-base reaction and
polymerization after mixing 2
pastes.
Acid-base reaction occurs
Fluoroalumino-silicate glass
in Paste A! and Polyacrylic
acid in Paste B.
Polymerization of
methacrylate monomers is
through dual cure. | The device is set by
acid-base reaction and
polymerization after mixing
2 pastes.
Acid-base reaction occurs
Fluoro-alumino-silicate
glass in Paste A! and
Polyacrylic acid in Paste B.
Polymerization of
methacrylate monomers is
through chemical cure. | The device consists of
several kinds of monomers to
be polymerized, and filler
elements.
The device is set by
polymerization.
Polymerization of
methacrylate monomers is
through light cure. |
Table 5.1
Page 5.3 of 5.5
6
7
9. Substantial equivalence:
The applicant device complies with all the requirements of ISO 9917-2: 2010 (Dentistry - Water-based cements -Part2: Resin-modified cements).
The curing mechanism of the applicant device and predicate device-are substantially equivalent in principle. Therefore, the applicant device and 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.
10. Differences
The following differences may be noted between GC Fuji Direct and the predicate device.
- There are slight differences in indications for use, however, differences are verbiage. The same applies to reference device, GC Fuji II LC Capsule.
- The applicant device is automixed with an automix tip while the predicate device is hand mixed. -
11. Conclusion
Based on similarities in intended use, mode of action, chemical composition, and performance testing. GC Fuji Direct is substantially equivalent to the predicate device.