Cerasmart Forte

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 GC America, Inc. Futoshi Fusejima Director of PE and Regulatory Affairs 3737 W. 127th St. Alsip, Illinois 60803 Re: K262202 Trade/Device Name: Cerasmart Forte Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: June 29, 2026 Received: June 29, 2026 Dear Futoshi Fusejima: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262202 - Futoshi Fusejima Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K262202 - Futoshi Fusejima Page 3 assistance/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, # MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K262202 Device Name Cerasmart Forte Indications for Use (Describe) Missing tooth structure in anterior and posterior teeth Areas of application: 1. Metal free indirect restorations: full crown, inlay, onlay, laminated veneer 2. Implant supported crown Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K262202 ## 510(k) Summary CERASMART FORTE Submitter: GC America Inc. 3737 W. 127th Street Alsip, IL 60803 Contact Person: Futoshi Fusejima Title: Director of PE and Regulatory Affairs Phone: (708)926-3050 Alternative Contact: Tamiko Scott Title: Regulatory Affairs Specialist Date Prepared: June 26, 202 | Trade/Device Name | CERASMART FORTE | | --- | --- | | Common or Usual Name | Tooth Shade Resin Material | | Regulatory Class | Class II | | Product Code | EBF | | Regulation Number | 21 CFR 872.3690 | Predicate Devices: | Product | Applicant | 510(k) No. | Code No. | Predicate/reference device | Decision DateUni | | --- | --- | --- | --- | --- | --- | | CERASMART | GC America Inc. | K133824 | EBF | Primary Predicate | 03/14/2014 | | GRADIA CORE | GC America Inc. | K082171 | EBF | Reference | 10/30/2008 | | Nmf004a (G-ænial Universal Injectable) | GC America Inc. | K173500 | EBF | Reference | 03/8/2018 | {5} **Device Description:** CERASMART FORTE is a hybrid ceramic for fixed all-ceramic dental restorations. The material is indicated for use of : Missing tooth structure in anterior and posterior teeth. Areas of application: 1. Metal free indirect restorations: full crown, inlay, onlay, laminated veneer. 2. Implant supported crown. For professional use only. **Intended Use/Indications for Use:** Missing tooth structure in anterior and posterior teeth. Areas of application: 1. Metal free indirect restorations: full crown, inlay, onlay, laminated veneer 2. Implant supported crown **Summary of Technological Characteristics:** CERASMART FORTE is a hybrid ceramic CAD/CAM block intended for the fabrication of fixed all-ceramic dental restorations, including metal-free indirect restorations such as full crowns, inlays, onlays, and laminate veneers, as well as implant-supported crowns. The block is mechanically milled using a dental CAD/CAM system to fabricate the intended restoration. After milling, the restoration is finished and polished, and then bonded to the tooth structure or attached to an implant abutment using conventional dental procedures. The device functions as a passive restorative material by replacing or restoring missing or defective tooth structure and restoring the anatomical form and function of the tooth. Applicant device and predicate devices are substantially equivalent in the following points. - Pre-cured composite block - Indications for Use; that is the material to use for indirect prosthetic restorations (crowns, inlays, and veneers) including crowns on implants - Provided in pre-cured block - Method of use - Performance evaluation Therefore, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices. The following difference may be noted between applicant device and predicate device. - The substances used in the applicant device differ from those used in the predicate device. Although the chemical composition is not identical, both the applicant and predicate device contain methacrylate based monomers, initiators, inorganic fillers, and pigments, {6} which are commonly used in dental composite resin materials including the reference devices; therefore, the two devices are considered comparable in material characteristics. The applicant device does not introduce any new indications, as all intended uses of the applicant device are included within the predicate device CERASMART. Furthermore, the biological safety of this product was evaluated in accordance with ISO 10993-1:2018, Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 7405:2018 and following the flowchart in "ISO 10993-1:2018 Figure 1 - Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process". Q-sub Q260748 was conducted June 15th, 2026, and this biological evaluation was conducted based on the FDA suggestions at Q260748. In conclusion, the applicant device is substantially equivalent to the predicate device in technological principle. ### Performance Data: The biological safety of this product was evaluated in accordance with ISO 10993-1:2018, Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 7405:2018 and following the flowchart in "ISO 10993-1:2018 Figure 1 - Summary of the systematic approach to a biological evaluation of medical devices as part of a risk management process". In accordance with ISO 10993-1:2018 "Annex A Endpoints to be addressed in a biological risk assessment", the following are contact and contact duration of this product with the body. | Category | : Externally communicating medical device | | --- | --- | | Contact | : Tissue/bone/dentin | | Contact duration | : Long term (> 30 d) | - ISO 10993-5 In Vitro Cytotoxicity - ISO 10993-10 Skin Sensitization - ISO 10993-23 Skin Irritation Additional bench testing based on the test with reference to ISO 10477:2020, ISO 4049:2019, ISO9917-1:2007, ADA specification No. 27-1993, JIS T 6517:2011, and the FDA guidance documents entitled "Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff". - Appearance - Shade - Surface finish {7} - Hardness - Flexural strength - Water sorption - Solubility - Color stability - Compressive strength - Elastic modulus - Radio-opacity {8} CERASMART FORTE Substantial Equivalence Chart | | Applicant device | Predicate device | Reference device 1 | Reference device 2 | Rational | | --- | --- | --- | --- | --- | --- | | Trade name | CERASMART FORTE | CERASMART K133824 | GRADIA CORE K082171 | Nmf004a (G-ænial Universal Injectable) K173500 | | | Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation | | | Product category | EBF | EBF | EBF | EBF | Applicant device is identical to predicate device and reference devices. | | Indications for Use | Missing tooth structure in anterior and posterior teeth. Areas of application: 1. Metal free indirect restorations: full crown, inlay, onlay, laminated veneer 2. Implant supported crown | The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants. | GRADIA CORE is intended to be used for restoration, core build-up and post cementation. | 1. Liner or base 2. Blocking out undercuts 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. Direct restorative for Class I, II, III, IV, V cavities 7. Core build-up | Applicant device is equivalent to predicate device. | | Device description | CERASMART FORTE is a hybrid ceramic for fixed all-ceramic dental restorations. | CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth. | GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE cartridge paste | NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades. | Applicant device is substantially equivalent to predicate device | {9} | | | | comprises four shades, Universal, Dentin, White and Blue. | | | | --- | --- | --- | --- | --- | --- | | Material Type | Pre-cured composite block | Pre-cured composite block | Dual-cured composite resin | Light-cured composite resin | Applicant device is equivalent to predicate device. | | Delivery form | Pre-cured block | Pre-cured block | Paste-paste formulation in a double-chamber syringe | Paste in a syringe | Applicant device is equivalent to predicate device. | | Chemical composition | Barium glass, methacrylate polymer, silicon dioxide, pigment | Barium glass, methacrylate polymer, silicon dioxide, pigment | Paste A: Fluoro-alumino-silicate glass, Di methacrylate, silicon dioxide, initiator, stabilizer, pigment, Paste B: Fluoro-alumino-silicate glass, Di methacrylate, silicon dioxide, initiator, stabilizer, pigment, | Barium glass, di methacrylate, initiator, pigment, silicon dioxide, stabilizer | Applicant device and predicate device are considered equivalent in that they are composed of inorganic fillers, methacrylate polymers, stabilizers, and pigments. | | Sterilization | Not a sterile medical device. | Not a sterile medical device. | Not a sterile medical device. | Not a sterile medical device. | The applicant device is the same as predicate device and reference devices. | | Storage temperature | 4 – 25°C | 4 – 25°C | 2 – 8°C | 4 – 25°C | The applicant device is the same as predicate device. | | Shelf-Life | 5 years | 5 years | 2 years | 3 years | The applicant device is the same as predicate device. | | Available shades | LT: B1, A1, A2, A3, A3.5, A4 HT: B1, A1, A2, A3, A3.5 | A1 HT, A2 HT, A3 HT, A3.5 HT, A4 HT, B1 HT, B2 HT, B3 HT, B4 HT, C1 HT, C2 HT, C3 HT, | Universal, Dentin, White, Blue | A1, A2, A3, A3.5, A4, A5, B1, B2, B3, B4, C1, C2, C3, C4, | Applicant device shades are included in the predicate device shades. | {10} | | | C4 HT, D2 HT, D3 HT, D4 HT, A1 LT, A2 LT, A3 LT, A3.5 LT, A4 LT, B1 LT, B2 LT, B3 LT, B4 LT, C1 LT, C2 LT, C3 LT, C4 LT, D2 LT, D3 LT, D4 LT, BL | | D2, D3, D4, E1, E2, E3, U AO1, AO2, AO3, AO3.5, AO4, AO5, WO, BW, XBW | | | --- | --- | --- | --- | --- | --- | | Direction for use | PREPARATION DESIGN MILLING FINISHING AND POLISHING CEMENTATION ADDITIONAL APPLICATION AND REPAIR CHARACTERIZATION | I. MILLING PROCEDURE II. ADDITIONAL APPLICATION AND REPAIR | 1. Loading cartridge into dispenser 2. Cavity preparation 3. Application of G-Premio BOND and G-Premio BOND DCA or GRADIA CORE SELF-ETCHING BOND A/B 4. Post cementation and core build-up 5. Contouring 6. Additional build-up | 1. Preparations 2. Shade Selection 3. Cavity Preparation 4. Bonding Treatment 5. Placement of G-aenial Universal Injectable 6. Light curing 7. Finishing and polishing | Differences are limited to wording and level of detail; method of use is the same as predicate device. | | Biocompatibility | Conformed to ISO-10993-1 and ISO 7405 | Conformed to ISO 10993-1 | Conformed to ISO-10993-1 | Conformed to ISO-10993-1 | | | Performance Testing | Reference to: FDA guidance document "Dental Composite Resin Devices, ISO 10477, ISO 4049, ISO 9917-1 and JIS T 6517 • Appearance • Shade • Surface finish • Hardness • Flexural strength • Water sorption • Solubility • Color stability • Compressive strength • Elastic modulus | ISO 10477 • Surface finish • Flexural strength • Water sorption • Solubility • Shade consistency • Color stability | ISO 4049 Type 2, Class 3 • Working time(sec.)(at 23°C) • Setting time(min.)(at 37°C) • Flexural strength • Water sorption • Solubility • Radio-opacity | ISO 4049 Type 1, Class 2, Group 1 • Stability to light • Depth of cure • Flexural strength • Water sorption • Solubility • Shade of restorative materials • Color stability after irradiation and water sorption • Radio-opacity | | {11} | | Radio-opacity | | | | | | --- | --- | --- | --- | --- | --- | | Appearance | Conformed | Conformed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Shade | Conformed | Conformed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Surface finish | Conformed | Conformed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Hardness | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Flexural strength | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Water sorption | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Solubility | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Colour stability | Conformed | Conformed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | Compressive strength | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | {12} | Elastic modulus | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | | --- | --- | --- | --- | --- | --- | | Radio-opacity | Passed | Passed | N/A | N/A | Applicant device is substantially equivalent to predicate device. | {13} In all instances, the CERASMART FORTE functioned as intended, and the outcomes were as expected. # **Conclusions:** Based on similarities in indications for use, technology, safety and effectiveness, the applicant device is substantially equivalent to the predicate devices.