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Sign in to claim this brandWhat ARUM DENTISTRY Co., Ltd. makes
The company produces ceramic materials for dental appliance fabrication, as well as preformed temporary and permanent suprastructures for dental implants. Their portfolio includes single-use temporary abutments and two-piece screw endosteal dental implants, with specific designs such as angled abutments and various branded fixtures like the ARENA Star and MontBlanc.
These devices are classified under FDA regulations as Class I and Class II, with entries listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for dental implant components and abutments.
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 ARUM Dentistry Co., Ltd. manufacture?
ARUM Dentistry Co., Ltd. specializes in dental devices, primarily focusing on ceramic materials for dental appliance fabrication. Their portfolio also includes preformed suprastructures for dental implants, categorized as both temporary (single-use) and permanent solutions. Additionally, they produce two-piece screw endosteal dental implants, such as angled abutments and branded fixtures like the ARENA Star and MontBlanc. These devices are designed to support dental restoration procedures.
Where is ARUM Dentistry Co., Ltd. based, and how does this affect its regulatory compliance?
ARUM Dentistry Co., Ltd. is based in the United States. As a U.S.-based manufacturer, the company must comply with FDA regulations governing medical devices, including classification, registration, and listing requirements. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. regulatory standards for dental implant components and abutments.
Which regulatory registries or databases list ARUM Dentistry Co., Ltd.’s devices?
ARUM Dentistry Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices, ensuring transparency and regulatory compliance. This listing helps healthcare providers and regulators track and verify the devices’ classification and compliance status under U.S. regulations.
How are ARUM Dentistry Co., Ltd.’s devices classified under FDA regulations?
ARUM Dentistry Co., Ltd.’s devices are classified under two categories by the FDA: Class I and Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use, potential risks, and benefits, ensuring appropriate regulatory oversight for dental implant suprastructures, abutments, and ceramic materials.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 557821945
Catalogue (2474)
Page 9 of 50| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cover Screw | CS3402GR | FDA UDI | Class II | Active |
| Arena | FM-ZD9822-B4 | FDA UDI | Class II | Active |
| ARENA Star | Arum-DR-28-B2 | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-WR-14-C2 | FDA UDI | Class II | Active |
| ARENA Star | Arum-ZR-20-D3 | FDA UDI | Class II | Active |
| ARENA Star | Arum-WR-12-C1 | FDA UDI | Class II | Active |
| ARENA Star | Arum-WR-14-A1 | FDA UDI | Class II | Active |
| ARENA Star | Arum-WR-25 | FDA UDI | Class II | Active |
| Cemented Abutment Mini | SACH4565M | FDA UDI | Class II | Active |
| ARUM NB Healing Abutment | HA5506GR | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-WR-22-D4 | FDA UDI | Class II | Active |
| Angled Abutment | SAAH554AR | FDA UDI | Class II | Active |
| Scan Healing Abutment | HAS7511RP | FDA UDI | Class II | Active |
| Arena | FM-Z10 | FDA UDI | Class II | Active |
| Arena | FM-ZD9826-B2 | FDA UDI | Class II | Active |
| Cemented Abutment | SACH4525RP | FDA UDI | Class II | Active |
| Scan Healing Abutment | HAS4507R | FDA UDI | Class II | Active |
| Master Fix | SALH5515RP | FDA UDI | Class II | Active |
| ARENA Star | Arum-ZR-12-A35 | FDA UDI | Class II | Active |
| Arena | EDEN-ZD1016-B1 | FDA UDI | Class II | Active |
| ARUM NB 1 SA Fixture | NB16008SS | FDA UDI | Class II | Active |
| Arena | FM-ZDS9814-B2 | FDA UDI | Class II | Active |
| ARUM NB 1 SA Fixture | NB13813S | FDA UDI | Class II | Active |
| Arena | FM-ZD9816-A3.5 | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-ZR-25-B4 | FDA UDI | Class II | Active |
| Angled Abutment Mini | SAAN404M | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-WR-20-A3 | FDA UDI | Class II | Active |
| NB Cemented Abutment | SACN4557R | FDA UDI | Class II | Active |
| Arena | FM-D16-A3 | FDA UDI | Class II | Active |
| NB Cemented Abutment | SACH4555R | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-WR-28-C1 | FDA UDI | Class II | Active |
| ARENA Star | AML525A3-WR | FDA UDI | Class II | Active |
| ARENA Star | Arum-ZR-22 | FDA UDI | Class II | Active |
| Arena | DC9825A35 | FDA UDI | Class II | Active |
| Arena | FM-ZDS9824-B1 | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-DR-28-A3 | FDA UDI | Class II | Active |
| Cemented Abutment | SACN4525RP | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-ZR-20-A35 | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-DR-25-A3 | FDA UDI | Class II | Active |
| Angled Abutment | SAAH454ARP | FDA UDI | Class II | Active |
| ARUM NB Healing Abutment | HA5509R | FDA UDI | Class II | Active |
| Customized Abutment | CIHE008P | FDA UDI | Class II | Active |
| Cemented Abutment Mini | SACN4035MP | FDA UDI | Class II | Active |
| ARUM NB Cover Screw | CS3403R | FDA UDI | Class II | Active |
| Arena | EDEN-ZD1010-A1 | FDA UDI | Class II | Active |
| ARUM NB 1 SA Fixture | NB14008SP | FDA UDI | Class II | Active |
| Arena | DC9825A3 | FDA UDI | Class II | Active |
| Cemented Abutment | SACH5515R | FDA UDI | Class II | Active |
| MontBlanc | MontBlanc-DR-18-B2 | FDA UDI | Class II | Active |
| Angled Abutment Mini | SAAH452AM | FDA UDI | Class II | Active |
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