(274 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental cement, with no mention of AI/ML or related concepts.
No.
The device is a luting cement used for the cementation of dental restorations, which is a structural rather than therapeutic function.
No
The device description and intended use clearly state that it is a luting cement for various dental restorations, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "resin modified glass ionomer luting cement" composed of two pastes in a syringe, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cementation of various dental restorations (inlays, onlays, crowns, bridges, posts) to the tooth structure. This is a therapeutic or restorative procedure, not a diagnostic one.
- Device Description: The device is a luting cement, a material used to bond things together. This is consistent with its intended use for cementation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies focus on biocompatibility and physical properties relevant to a dental cement (working time, setting time, strength, radiopacity), not on diagnostic accuracy metrics.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening. This device's function is purely for the physical bonding of dental restorations.
N/A
Intended Use / Indications for Use
-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.
Product codes
EMA
Device Description
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
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)
Non-Clinical Performance Testing: Biocompatibility assessment completed according to ISO 10993-1:2009. Cytotoxicity (L929 MEM Elution Test) based on ISO 10993-5 criteria. Sensitivity (Kligman Maximization Test) based on ISO 10993-10 criteria. Irritation (Intracutaneous Injection Test) based on ISO 10993-10 criteria. Biocompatibility deemed acceptable.
Performance Bench Tests: Confirmed device conforms to ISO 9917-2: 2017 specifications. Performance testing included Appearance (no extraneous matter, free of gelation), Working time (indenter makes complete circular indentation), Setting time (indenter fails to make complete circular indentation), Flexural strength (More than 25 MPa), 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.)
Flexural strength: More than 25 MPa
Radiopacity: More than equivalent thickness of aluminum
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
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) 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
2
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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3
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 Street
| Alsip, IL 60803 | |
|---|---|
| Contact Person: | |
| e-mail: | |
| Phone: | |
| Alternate Contact: | |
| e-mail: | |
| Phone: | |
| Fax: | Mark Heiss, D.D.S. |
| mark.heiss@gc.dental | |
| (708) 926-3090 | |
| Lori Rietman | |
| lori.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 Cement | |
| Class II, 872.3275 | |
| EMA |
-
- 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
4
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 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 |
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
5
| GC FujiCEM 2 (Improved) | GC FujiCEM |
|---|---|
| Fluoro-alumino-silicate glass contained in Paste A and | |
| Polyacrylic acid contained in Paste B react in the | |
| presence of water contained from the paste B. | |
| 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. | |
| Methacrylates contained in Paste A polymerize by | |
| polymerization initiator contained in Paste B. In | |
| addition, they also polymerize by light irradiation | |
| thanks to photo polymerization initiator contained in | |
| Paste A. | Fluoro-alumino-silicate glass contained in Paste A and |
| Polyacrylic acid contained in Paste B react in the | |
| presence of water contained from the paste B. | |
| 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. | |
| Methacrylates contained in Paste A polymerize by | |
| polymerization initiator contained in Paste B. | |
| This material set by the above two reactions. 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. | This material set by the above two reactions. 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. |
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.
6
| 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-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 | 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. Class III and V restorations - Restoration of primary teeth
- Core Build-up
- Cases where radiopacity is
required - Base material for Class 1 and
Class II cavities using a sandwich
laminate technique | GC GAM-100 is intended to be
used for cementing all types of
ceramic, resin, and metal-based
inlays, onlays, crown and
bridges, and post. |
| Product
description | The device consists of 2 pastes
filled in a dual barrel syringe.
Paste A and B are automixed
with an automix tip and directly
applied to restorations or the
prepared cavity. | The device consists of 2 pastes
filled in a Paste Pak Cartridge.
Paste A and B are dispensed with
Paste Pak Dispenser and hand
mixed. The mixed cement is
applied to restorations or the
prepared cavity. | 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 device consists of 2 pastes
filled in a one body syringe.
Paste A and B are automixed
with an automix tip and directly
applied to restorations or the
prepared cavity. |
| Instruction for use | 1. Tooth preparation - Restoration preparation
- Dispensing
- Cementation
- Cleaning up excess cement
- Finishing restoration and check
occlusion. | 1. Tooth preparation - Restoration preparation
- Dispensing
- mixing pastes
- Cementation
- Cleaning up excess cement
- Finishing restoration and check
occlusion. | 1. Tooth preparation - Mix of 2 pastes
- Application to cavity
- Finishing | 1. Tooth preparation
- Restoration preparation
- Dispensing
- Cementation
- Cleaning up excess cement
- Finishing restoration and
check occlusion. |
| Light curing
specification | Optionally, tack cure using light for
removing excess cement. | | Light cure using a light curing
unit.
10 sec. (High Power LED Light)
(>1200mW/cm2)
20 sec. (Halogen/LED) (700
mW/cm2) | light cure all surfaces/margins for
20 seconds each (Halogen/LED
700mW/cm2). |
| Technological
Characteristics
and Mode of
action | 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.
It is also partially hardened through
light cure (tack cure). This is used
for removing excess cement. | 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 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
polymerization after mixing 2
pastes.
Polymerization of methacrylate
monomers is through dual cure. |
| Sizes | 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 | 1 . GC FujiCEM Refill (Automix
compatible)
Paste Pak Cartridge (13.3g / 7.2mL)
(2) with mixing pad (No.22) - GC FujiCEM Automix
Paste Pak Cartridge (13.3g / 7.2mL)
(2), GC FujiCEM Mixing Tip (44) - Paste Pak Dispenser (1) | 1 x Paste Pak Cartridge SL (14.9g /
7.2mL)
20 x GC Fuji Mixing Tip SL with
intraoral tip
1 x Paste Pak Dispenser II | 1. G-CEM Automix syringe 4.8 g
(2.7 mL) (2), G-CEM Automix Tip
Regular (20) - G-CEM Automix Tip Regular (20)
- G-CEM Automix Tip for endo
including 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 require
sterilization. | This device does not require
sterilization. | This device does not require
sterilization. | This device does not require
sterilization |
7
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.