(237 days)
- 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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to include all your requested points:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (ISO 9917-2:2010) | Reported Device Performance (GC Fuji Direct) |
|---|---|---|
| Appearance | No visible sign of extraneous matter, Free of any gelation | Conforms to requirements |
| Working time | The indenter shall make a complete circular indentation. | Conforms to requirements |
| Setting time | The indenter shall fail to make a complete circular indentation. | Conforms to requirements |
| Flexural strength | More than 25 MPa | Conforms to requirements |
| Radiopacity | More than equivalent thickness of aluminum | Conforms to requirements |
| Shade and color stability | Shade: Shall match with the manufacturer's nominated shade guide; Color stability: No significant change from the reference specimen | Conforms to requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing against ISO standards and biocompatibility assessments. Therefore, there isn't a "test set" in the context of a clinical study with human or biological samples in the way this question typically implies for AI/diagnostic devices. The data provenance is related to laboratory testing, likely conducted by or for GC America Inc., a US-based company, referencing the specified international standards. No country of origin for the specific test data is given beyond the company's location. The testing appears to be prospective (as part of the 510(k) submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a bench test and biocompatibility assessment against technical specifications rather than an evaluation requiring expert-established ground truth on a test set (e.g., medical image interpretation). The "ground truth" for these tests is the quantitative and qualitative requirements of the ISO standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This is a bench test against technical specifications, not a study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This device is a dental cement, not an AI software/diagnostic device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a dental cement, not an algorithm, so this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing is adherence to the technical specifications defined in ISO 9917-2:2010 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the protocols outlined in ISO 10993-1:2009, ISO 10993-5, and ISO 10993-10 for biocompatibility. These are objective, predefined standards for material properties and biological response.
8. The sample size for the training set
N/A. This is a dental material, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
N/A. As there is no training set for an AI model, this question is not applicable.
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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
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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
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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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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)
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- 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.
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| Table 5.1 | |||||
|---|---|---|---|---|---|
| Applicant device | Primary Device | Reference Device | Reference Device | Reference Device | |
| Trade name | GC Fuji DirectK172382 | GC FUJI FILLING LCK051427 | GC Fuji II LC CapsuleK993973 | GC FujiCEM 2K001730 | GC KaloreK082434 |
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Productcategory | Resin-modified glassionomer cement | Resin-modified glassionomer cement | Resin-modified glass ionomercement | Radiopaque reinforcedglass ionomer Lutingcement | Light-cured compositerestorative |
| Paste/PasteratioOrPowder/Liquidratio | 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 forUse | 1. Class III and V restorations2. Restoration of primary teeth3. Core Build-up4. Cases where radiopacity isrequired5 Base material for Class 1and Class II cavities using asandwich laminate technique | 1. Class III and Vrestorations, particularly forcervical erosions and rootsurface caries2. Restoration of primaryteeth3. Core build up4. Cases where radiopacity isrequired5. As a base or a liner | 1. Class III and V restoration;particularly areasof cervical erosion,abfraction lesions androot surface caries2. Restoration of primary teeth3. As a base of liner4. Core build-ups/block-outs(particularly of vital teeth)5. Cases in which aradiopaque restoration isrequired | 1. Cementation ofmetal-based inlays, onlays,crowns and bridges2. Cementation of resininlays, onlays, crowns andbridges3. Cementation of allceramic inlays4. Cementation of highstrength (zirconia based) allceramic crowns and bridges5. Cementation of metal,ceramic and fiber posts | 1. Direct restorative forClass III, IV, V cavities.2. Direct restorative forwedge-shaped defectsand root surfacecavities.3. Direct restorative forveneers and diastemaclosure.4. Direct restorative forClass I and II cavities. |
| Productdescription | The device consists of 2pastes filled in cartridges.Paste A and B areautomixed with an automixtip and directly applied to theprepared cavity.The bioactive material setsby acid-base reaction offluoroalumino-silicate glassand Polyacrylic acid, andpolymerization ofmethacrylate monomers. | The device consists of 2pastes filled in cartridges.Paste A and B are mixed anddirectly applied to theprepared cavity.The material sets byacid-base reaction offluoroalumino-silicate glassand Polyacrylic acid, andpolymerization ofmethacrylate monomers. | The device consists of powderand liquid filled in a capsule.Powder & liquid are mixed withelectric capsule mixers. Themixed material is directlyapplied to a prepared cavityusing a capsule applier.The material sets by acid-basereaction offluoroalumino-silicate glassand Polyacrylic acid, andpolymerization ofmethacrylate monomers. | The device consists of 2pastes filled in a Paste PakCartridge. The material isdispensed with GC PastePak Dispenser andhand-mixed. Optionally GCFujiCEM Mixing Tip isavailable for automixingwhile pastes dispensation. | The device is alight-cured micro-filledradiopaque compositeresin for the restorationof both anterior andposterior teeth. Thedevice consists of twodelivery systems,Unitip and Syringes.The system isavailable in a variety ofshades. |
| Table 5.1 (Continued) | |||||
| Instruction foruse | 1. Tooth preparation2. Mix of 2 pastes3. Application to cavity4. Finishing | 1. Tooth preparation2. Mix of 2 pastes3. Application to cavity4. Finishing | 1. Tooth preparation2. Mix of powder and liquid3. Application to cavity4. Finishing | 1. Tooth preparation2. Restorationpreparation3. Mix of 2 pastes4. Cementation | 1. Tooth Preparation2. Bonding Treatment3. Placement of GC KALORE4. Contouring before Light Curing6. Light Curing7. Finishing and Polishing |
| Light curingspecification | Light cure using a light curingunit.10 sec. (High Power LED Light)(>1200mW/cm2)20 sec. (Halogen/LED) (700mW/cm2) | Light cure the material with avisible light curing device.In the case of G-Light,light-cure for 20 seconds. | Light-cure for 20 secondsusing a suitable visible lightcuring device (470nmwavelength) | Light cure GC KALORE usinga light curing unit.In the case of High powerLED (more than1200mW/cm2) light-cure for10 seconds.In the case of Halogen / LED(700mW/cm2) light-cure for20 seconds. | |
| TechnologicalCharacteristicsand Mode ofaction | The device is set by acid-basereaction and polymerizationafter mixing 2 pastes.Acid-base reaction occursFluoroalumino-silicate glass inPaste A!and Polyacrylic acid inPaste B. | The device is set by acid-basereaction and polymerizationafter mixing 2 pastes.Acid-base reaction occursFluoroalumino-silicate glass inPaste A!and Polyacrylic acid inPaste B. | The device is set byacid-base reaction andpolymerization after mixing 2pastes.Acid-base reaction occursFluoroalumino-silicate glassin Paste A! and Polyacrylicacid in Paste B.Polymerization ofmethacrylate monomers isthrough dual cure. | The device is set byacid-base reaction andpolymerization after mixing2 pastes.Acid-base reaction occursFluoro-alumino-silicateglass in Paste A! andPolyacrylic acid in Paste B.Polymerization ofmethacrylate monomers isthrough chemical cure. | The device consists ofseveral kinds of monomers tobe polymerized, and fillerelements.The device is set bypolymerization.Polymerization ofmethacrylate monomers isthrough light cure. |
Table 5.1
Page 5.3 of 5.5
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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.
§ 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.