(274 days)
- -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 (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
- Cementation of metal, ceramic and fiber posts -
GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.
The provided document is a 510(k) summary for a dental cement (GC FujiCEM 2 (Improved)). It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about software or AI-based devices. Therefore, a table of acceptance criteria and reported device performance for an AI/software device cannot be generated from this text.
The document discusses the physical and chemical properties of the dental cement through performance bench tests and biocompatibility assessments against established ISO standards.
Here's an analysis of the available information regarding the device's evaluation, although it's for a physical dental cement product, not an AI device:
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Software):
| Property | Acceptance Criteria (Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993-1:2009 standards | Acceptable per biological evaluation results |
| Cytotoxicity | Based on criteria of ISO 10993-5 | Pass |
| Sensitivity | Based on criteria of ISO 10993-10 | Pass |
| Irritation | Based on criteria of ISO 10993-10 | Pass |
| Performance Bench Tests (ISO 9917-2: 2017) | Conforms to ISO 9917-2: 2017 and company standard | Suitable for intended use |
| Appearance | No visible sign of extraneous matter, free of any gelation | Conforms to requirement |
| Working time | Indenter shall make a complete circular indentation | Conforms to requirement (implies appropriate working time) |
| Setting time | Indenter shall fail to make a complete circular indentation | Conforms to requirement (implies appropriate setting time) |
| Flexural strength | More than 25 MPa | Conforms to requirement (implies > 25 MPa) |
| Radiopacity | More than equivalent thickness of aluminum | Conforms to requirement (implies > equivalent thickness of Al) |
2. Sample size used for the test set and the data provenance:
- Not applicable for AI/Software. The document describes non-clinical bench testing. The sample sizes for each specific test (e.g., number of specimens for flexural strength) are not explicitly stated within this summary. Data provenance is implied to be from the manufacturer's own testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for AI/Software. Ground truth for dental cement properties is established through standardized physical and chemical testing methods, not expert consensus in the way it's used for AI diagnostic outputs.
4. Adjudication method for the test set:
- Not applicable for AI/Software. The performance criteria for the dental cement are objective metrics measured by equipment and standardized procedures, not subjective interpretations requiring adjudication.
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:
- Not applicable. This document is for a dental cement, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (dental cement), not an algorithm or software. No standalone algorithm performance was assessed.
7. The type of ground truth used:
- For biocompatibility: Ground truth is defined by the criteria and methods outlined in ISO 10993 series standards.
- For performance bench tests: Ground truth is defined by the specifications and methods in ISO 9917-2: 2017 (Dentistry - Water-based cements - Part 2: Resin-modified cements) and the company's internal standards. These are objective, measurable physical and chemical properties.
8. The sample size for the training set:
- Not applicable. This is a physical medical device. There is no training set in the context of AI/machine learning.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2019
GC America Inc. Mark Heiss Director, Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803
Re: K182854
Trade/Device Name: GC FujiCEM 2 (Improved) Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: April 12, 2019 Received: April 16, 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.
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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) 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 Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name GC FujiCEM 2 (Improved)
Indications for Use (Describe)
- -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 (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
- Cementation of metal, ceramic and fiber posts -
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/0 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color, and there are single quotation marks before and after the letters. The letters are slightly italicized, giving them a dynamic appearance. The background is plain white.
C AMER 3737 W 127th STRE ALSIP, ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 926-9100 www.gcamerica.com
| 1. Submitter Information:GC America Inc.3737 W. 127th StreetAlsip, IL 60803 | |
|---|---|
| Contact Person:e-mail:Phone:Alternate Contact:e-mail:Phone:Fax: | Mark Heiss, D.D.S.mark.heiss@gc.dental(708) 926-3090Lori Rietmanlori.rietman@gc.dental(708) 926-3092(708) 926-9100 |
| Date Prepared: | July 8, 2019 |
| 2. Device Name: | |
| Proprietary Name:Classification Name:Device Classification:Product Code: | GC FujiCEM 2 (Improved)Dental CementClass II, 872.3275EMA |
-
- Predicate Devices:
| Product | Applicant | 510(k) No. | Code No | Predicate | Decision Date |
|---|---|---|---|---|---|
| GC FujiCEM | GC America Inc. | K001730 | EMA | Primary | 07/17/2000 |
| GC Fuji Direct | GC America Inc. | K172382 | EMA | Reference | 04/02/2018 |
| GC G-CEM Automix | GC America Inc. | K073283 | EMA | Reference | 02/20/2008 |
4. Description of Device:
GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.
GC FujiCEM 2 (Improved) Package:
- Single Pack Automix ●
- Syringe (9.2 g / 5 mL) QTY: 1
- GC Mixing Tip QTY: 15
- Triple Pack Handmix ●
- Syringe (9.2 g / 5 mL) QTY: 3
- Mixing Pad- QTY: 1
- Triple Pack Automix .
- Syringe (9.2 g / 5 mL) QTY: 3
- GC Mixing Tip QTY: 45
Shades available:
Yellow, Brown
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)
1
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ર. Indications for Use Statement:
- 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 (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges
- Cementation of metal, ceramic and fiber posts .
6. Non-Clinical Performance Testing:
Biocompatibility: 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
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 FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement and does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours.
In conclusion, biocompatibility of GC FujiCEM 2 (Improved) is acceptable device from the biological evaluation result.
Performance Bench Tests: It is confirmed that the device conforms to the required specifications of ISO 9917-2: 2017 (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 matterFree 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 |
7. Clinical Performance Testing
No clinical testing has been performed on this device.
-
- Substantial equivalence:
The applicant device complies with all the requirements of ISO 9917-2: 2017 (Dentistry - Water-based cements -Part2: Resin-modified cements).
- Substantial equivalence:
The curing mechanism of the applicate 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.
- 2
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| GC FujiCEM 2 (Improved) | GC FujiCEM |
|---|---|
| Fluoro-alumino-silicate glass contained in Paste A andPolyacrylic acid contained in Paste B react in thepresence of water contained from the paste B.Aluminum ion, Strontium ion and Fluoride ion arereleased from Fluoro-alumino-silicate glass due to thisreaction. Of these ions, Aluminum ion and Strontiumion crosslink the polyacrylic acid and form hydrogel.Fluoride ion doesn't react, it remains inside hydrogel asion.Methacrylates contained in Paste A polymerize bypolymerization initiator contained in Paste B. Inaddition, they also polymerize by light irradiationthanks to photo polymerization initiator contained inPaste A. | Fluoro-alumino-silicate glass contained in Paste A andPolyacrylic acid contained in Paste B react in thepresence of water contained from the paste B.Aluminum ion, Strontium ion and Fluoride ion arereleased from Fluoro-alumino-silicate glass due to thisreaction. Of these ions, Aluminum ion and Strontium ioncrosslink the polyacrylic acid and form hydrogel.Fluoride ion doesn't react, it remains inside hydrogel asion.Methacrylates contained in Paste A polymerize bypolymerization initiator contained in Paste B. |
| This material set by the above two reactions. The setmaterial contains fluoride ion inside as free ion. Theseions can be gradually release from the setting materialin very small amounts with time. | This material set by the above two reactions. The setmaterial contains fluoride ion inside as free ion. Theseions can be gradually release from the setting material invery small amounts with time. |
Differences
The following differences may be noted between GC FujiCEM 2 (Improved) and the predicate device.
- The differences are for clarification of Indications for Use. -
- The applicant device is hardened through chemical cure and partially hardened through light cure (tack curing). This function is used for removing excess cement. On the primary device is hardened through just chemical cure.
- -The applicant device is automixed using a static mixing tip, while primary device is hand mixed.
- -The applicant device is a resin modified glass ionomer cement for luting while the predicate device, GC Fuji Direct, is resin modified glass ionomer cement for filling.
- The applicant device is resin modified glass ionomer cement while the predicate device, GC G-CEM -Automix, is self-adhesive resin cement for luting.
Below is a comparison table between the applicant device, primary device and reference devices, showing the similarities between devices.
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| Applicant Device | Primary Device | Reference Device | Reference Device | |
|---|---|---|---|---|
| Trade name | GC FujiCEM 2 (Improved) | GC FujiCEM | GC Fuji Direct | GC G-CEM Automix |
| K182854 | K001730 | K172382 | K073283 | |
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Product | Resin modified glass ionomer | Resin modified glass ionomer | Resin-modified glass ionomer | Self-adhesive resin cement |
| category | cement | cement | cement | |
| Paste/Paste ratio | Paste A / Paste B = 1.0 / 1.0 (w/w) | Paste A / Paste B = 2.0 / 1.0 (w/w) | Paste A / Paste B = 1.6 / 1.0 w/w) | Paste A / Paste B = 1.3 / 1.0 (w/w) |
| Indications for Use | 1. Cementation of metal-basedinlays, onlays, crowns andbridges2. Cementation of resin inlays,onlays, crowns and bridges3. Cementation of all ceramicinlays4. Cementation of high strength(e.g. zirconia based, lithiumdisilicate) ceramic onlays,crowns and bridges5. Cementation of metal, ceramicand fiber posts | 1. Cementation of metal-basedinlays, onlays, crowns andbridges2. Cementation of resin inlays,onlays, crowns and bridges3. Cementation of all ceramic inlays4. Cementation of high strength(zirconia based) all ceramiccrowns and bridges5. Cementation of metal, ceramicand fiber posts | 1. Class III and V restorations2. Restoration of primary teeth3. Core Build-up4. Cases where radiopacity isrequired5. Base material for Class 1 andClass II cavities using a sandwichlaminate technique | GC GAM-100 is intended to beused for cementing all types ofceramic, resin, and metal-basedinlays, onlays, crown andbridges, and post. |
| Productdescription | The device consists of 2 pastesfilled in a dual barrel syringe.Paste A and B are automixedwith an automix tip and directlyapplied to restorations or theprepared cavity. | The device consists of 2 pastesfilled in a Paste Pak Cartridge.Paste A and B are dispensed withPaste Pak Dispenser and handmixed. The mixed cement isapplied to restorations or theprepared cavity. | The device consists of 2 pastesfilled in cartridges. Paste A and Bare automixed with an automixtip and directly applied to theprepared cavity. | The device consists of 2 pastesfilled in a one body syringe.Paste A and B are automixedwith an automix tip and directlyapplied to restorations or theprepared cavity. |
| Instruction for use | 1. Tooth preparation2. Restoration preparation3. Dispensing4. Cementation5. Cleaning up excess cement6. Finishing restoration and checkocclusion. | 1. Tooth preparation2. Restoration preparation3. Dispensing4. mixing pastes5. Cementation6. Cleaning up excess cement7. Finishing restoration and checkocclusion. | 1. Tooth preparation2. Mix of 2 pastes3. Application to cavity4. Finishing | 1. Tooth preparation2. Restoration preparation3. Dispensing4. Cementation5. Cleaning up excess cement6. Finishing restoration andcheck occlusion. |
| Light curingspecification | Optionally, tack cure using light forremoving excess cement. | Light cure using a light curingunit.10 sec. (High Power LED Light)(>1200mW/cm2)20 sec. (Halogen/LED) (700mW/cm2) | light cure all surfaces/margins for20 seconds each (Halogen/LED700mW/cm2). | |
| TechnologicalCharacteristicsand Mode ofaction | The device is set by acid-basereaction and polymerization aftermixing 2 pastes.Acid-base reaction occurs Fluoro-alumino-silicate glass in Paste Aand Polyacrylic acid in Paste B.Polymerization of methacrylatemonomers is through chemicalcure.It is also partially hardened throughlight cure (tack cure). This is usedfor removing excess cement. | The device is set by acid-basereaction and polymerization aftermixing 2 pastes.Acid-base reaction occursFluoro-alumino-silicate glass inPaste A and Polyacrylic acid inPaste B.Polymerization of methacrylatemonomers is through chemicalcure. | The device is set by acid-basereaction and polymerization aftermixing 2 pastes.Acid-base reaction occursFluoroalumino-silicate glass inPaste A and Polyacrylic acid inPaste B.Polymerization of methacrylatemonomers is through dual cure | The device is set bypolymerization after mixing 2pastes.Polymerization of methacrylatemonomers is through dual cure. |
| Sizes | Single Pack AutomixSyringe (9.2 g / 5 mL) QTY: 1GC Mixing Tip – QTY: 15Triple Pack HandmixSyringe (9.2 g / 5 mL) QTY: 3Mixing Pad- QTY: 1Triple Pack AutomixSyringe (9.2 g / 5 mL) QTY: 3GC Mixing Tip – QTY: 45 | 1 . GC FujiCEM Refill (Automixcompatible)Paste Pak Cartridge (13.3g / 7.2mL)(2) with mixing pad (No.22)2. GC FujiCEM AutomixPaste Pak Cartridge (13.3g / 7.2mL)(2), GC FujiCEM Mixing Tip (44)3. Paste Pak Dispenser (1) | 1 x Paste Pak Cartridge SL (14.9g /7.2mL)20 x GC Fuji Mixing Tip SL withintraoral tip1 x Paste Pak Dispenser II | 1. G-CEM Automix syringe 4.8 g(2.7 mL) (2), G-CEM Automix TipRegular (20)2. G-CEM Automix Tip Regular (20)3. G-CEM Automix Tip for endoincluding extension tip (10) |
| Shades | Yellow, Brown | Yellow | A1, A2, A3 based on Vita® shades | A2 (Vita® shade), AO3 (opaque),BO1 (opaque) and Translucent |
| Sterility | This device does not requiresterilization. | This device does not requiresterilization. | This device does not requiresterilization. | This device does not requiresterilization |
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9. Conclusion
Based on similarities in intended use, mode of action, chemical composition, and performance testing, GC FujiCEM 2 (Improved) 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.