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Sign in to claim this brandGc America Inc.
US
Last updated September 17, 2026
What Gc America Inc. makes
Gc America Inc. manufactures dental materials and devices, including ceramic-based dental appliance fabrication materials, dental composites (both light-cured and conventional), glass ionomer cements, silicone impression materials, reusable dental impression trays, and preformed permanent dental implant suprastructures. Their portfolio also includes dental acrylic resins and multiple formulations of dental composites under the GC Initial™ brand.
The company’s products are regulated under FDA classifications, with most falling into Class I or Class II. Devices are listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gc America Inc. manufacture?
Gc America Inc. specializes in dental materials and devices. Their portfolio includes ceramic-based dental appliance fabrication materials, dental composites (both light-cured and conventional), glass ionomer cements, silicone impression materials, reusable dental impression trays, and preformed permanent dental implant suprastructures. They also produce dental acrylic resins and multiple formulations of dental composites under the GC Initial™ brand, catering primarily to dental professionals.
Where is Gc America Inc. based?
Gc America Inc. is headquartered in the United States. The company’s location in the U.S. ensures compliance with FDA regulations governing the manufacturing and distribution of its dental devices.
Which regulatory registries or databases list Gc America Inc.’s devices?
Gc America Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance tracking for dental materials and devices regulated under FDA classifications.
How are Gc America Inc.’s devices classified under FDA regulations?
Gc America Inc.’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.
Why do some of Gc America Inc.’s devices require a 510(k) premarket notification?
The FDA requires a 510(k) premarket notification for Class II devices, which are deemed to have moderate risk. These notifications demonstrate that a new device is substantially equivalent to a legally marketed predicate device in terms of safety and performance. Since Gc America Inc. manufactures both Class I (lower risk) and Class II (moderate risk) devices, some of their products undergo this review process to ensure compliance with regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 3737 W 127th St, ALSIP, IL, 60803
- Website
- gcamerica.com
- —
- —
- [email protected]
- Phone
- +1(708)597-0900
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1410097
- DUNS Number
- 005473608
Catalogue (5947)
Page 2 of 119| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GC Initial™ | 010329 | FDA UDI | Class II | Active |
| Exajet™ | 137611 | FDA UDI | Class II | Active |
| GC Initial™ | 874075 | EUDAMEDFDA UDI | Class II | Active |
| Kalore™ | 003620 | FDA UDI | Class II | Active |
| GC Fuji IX GP® | 425070 | FDA UDI | Class II | Active |
| GC Initial™ | 876404 | FDA UDI | Class II | Active |
| GC Initial™ | 876151 | FDA UDI | Class II | Active |
| Coe® | 260221 | FDA UDI | Class I | Active |
| GC Initial™ | 012934 | FDA UDI | Class II | Active |
| Optiglaze™ | 008415 | FDA UDI | Class II | Active |
| Optiglaze™ | 008408 | FDA UDI | Class II | Active |
| GC Fuji TRIAGE® | 013605 | FDA UDI | Class II | Active |
| GC Initial™ | 877002 | FDA UDI | Class II | Active |
| GC Initial™ | 877007 | FDA UDI | Class II | Active |
| GC Fuji II® | 000095 | FDA UDI | Class II | Active |
| GC Initial™ | 876427 | FDA UDI | Class II | Active |
| Coe® | 263584 | FDA UDI | Class I | Active |
| GC Initial™ | 872053 | FDA UDI | Class II | Active |
| GC Initial™ | 874103 | FDA UDI | Class II | Active |
| Kalore™ | 003606 | FDA UDI | Class II | Active |
| G-aenial™ | 012354 | FDA UDI | Class II | Active |
| GC Initial™ | 875059 | EUDAMEDFDA UDI | Class II | Active |
| Gradia® | 002442 | FDA UDI | Class II | Active |
| GC Initial™ | 874027 | EUDAMEDFDA UDI | Class II | Active |
| GC Initial™ | 875853 | FDA UDI | Class II | Active |
| Coe-Comfort™ | 341001 | FDA UDI | Class II | Active |
| GC Initial™ | 876180 | EUDAMEDFDA UDI | Class II | Active |
| Cytrans Granules | 10007516 | FDA UDI | Class II | Unknown |
| G-aenial™ | 401100 | FDA UDI | Class II | Active |
| Coe-Flex® | 131302 | FDA UDI | Class II | Active |
| Kalore™ | 003591 | FDA UDI | Class II | Active |
| GC Initial™ | 874591 | FDA UDI | Class II | Unknown |
| GC Initial™ | 876402 | FDA UDI | Class II | Active |
| GC Initial™ | 875634 | FDA UDI | Class II | Active |
| GC Initial™ | 875580 | FDA UDI | Class II | Active |
| GC Initial™ | 875823 | FDA UDI | Class II | Active |
| EXAlence™ | 137712 | FDA UDI | Class II | Active |
| Gc Crowntek™ | 412093 | FDA UDI | Class I | Unknown |
| GC Initial™ | 874143 | FDA UDI | Class II | Active |
| GC Initial™ | 870822 | FDA UDI | Class II | Active |
| Nature-Cryl® | 349792 | FDA UDI | Class II | Active |
| Equia® | 452003 | FDA UDI | Class II | Active |
| GC Initial™ | 875133 | FDA UDI | Class II | Active |
| GC Initial™ | 870252 | FDA UDI | Class II | Active |
| GC Initial™ | 875102 | FDA UDI | Class II | Active |
| GC Initial™ | 870056 | FDA UDI | Class II | Active |
| Cerasmart™ | 012514 | FDA UDI | Class II | Active |
| Nature-Cryl® | 349822 | FDA UDI | Class II | Active |
| GC Initial™ | 877077 | FDA UDI | Class II | Active |
| GC Initial™ | 874566 | FDA UDI | Class II | Unknown |
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