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Sign in to claim this brandCybermed Inc.
South Korea·KR-MF-000009356
Last updated September 17, 2026
What Cybermed Inc. makes
Cybermed Inc. manufactures dental implant suprastructures, including preformed permanent fixtures and two-piece screw endosteal implants. Their portfolio includes fixtures like the CORE1 and REBORN, along with various abutments such as angled, cement-retained, and milling types for dental restoration.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from South Korea.
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 Cybermed Inc. manufacture?
Cybermed Inc. specializes in dental implant-related devices. Their primary products include permanent preformed dental implant suprastructures and two-piece screw endosteal dental implants. Examples include fixtures like the CORE1 and REBORN, as well as various abutments (angled, cement-retained, and milling types) designed for dental restoration. These devices are engineered to support dental prosthetics and implant stability.
Where is Cybermed Inc. based, and how does that affect its regulatory standing?
Cybermed Inc. is headquartered in South Korea, which means its devices must comply with both Korean regulatory requirements and international standards (such as FDA or EU MDR) if marketed globally. While the company’s location influences its regulatory pathways, individual devices—like the CORE1 Fixture or Cement Abutment—must undergo their own authorisation processes (e.g., FDA 510(k) clearance or CE marking) before commercialisation, depending on the target market.
Which regulatory registries list Cybermed Inc.’s devices, and why?
Cybermed Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which means they have been assigned a UDI for traceability and compliance tracking in the U.S. market. This listing is required for Class II devices (the classification for Cybermed’s dental implants) to ensure transparency in the supply chain and facilitate post-market surveillance. Listing in the UDI database does not imply approval—it’s a mandatory step for authorised devices sold in regulated jurisdictions.
How are Cybermed Inc.’s dental implant devices classified under regulatory frameworks?
Cybermed Inc.’s dental implant devices—such as the CORE1 Fixture or Angled Abutment—are classified as Class II under regulatory schemes like the FDA’s classification system. This classification applies because these devices are non-invasive but require special controls (e.g., performance testing, clinical evaluation) to ensure safety and effectiveness in dental restoration. Class II status means they undergo stricter scrutiny than Class I but less than Class III, reflecting their role in critical patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 6-26, 6-26, Yuseong-daero1205beon-gil, Yuseong-gu Daejeon 34104 Republic of Korea, Daejeon, South Korea
- Website
- www.ondemand3d.com/en/
- —
- —
- [email protected]
- Phone
- +82 70 5118 7128
- PRRC Contact
- Kijung Kim
- EUDAMED SRN
- KR-MF-000009356
- FDA FEI Number
- 3003781339
- DUNS Number
- 688248447
Catalogue (2786)
Page 38 of 56| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Temporary Abutment | CTANM4593S | FDA UDI | Class II | Active |
| Milling Abutment | CMAHM4555E | FDA UDI | Class II | Active |
| CORE1 Fixture | C1M3513S | FDA UDI | Class II | Active |
| Cement Abutment | CCANR5045S | FDA UDI | Class II | Active |
| REBORN Fixture | IC1R4508OC | FDA UDI | Class II | Active |
| Cement Abutment | CCANM4061E | FDA UDI | Class II | Active |
| Healing Abutment (SCAN) | CTIHR406S | FDA UDI | Class II | Active |
| Angled Abutment | CAA15NR5072ES | FDA UDI | Class II | Active |
| Temporary Abutment | CTANM4593E | FDA UDI | Class II | Active |
| Cement Abutment | CCAHM4574 | FDA UDI | Class II | Active |
| Temporary Abutment | ICTANM4591S | FDA UDI | Class II | Active |
| Temporary Abutment | CTANM4092E | FDA UDI | Class II | Active |
| Cement Abutment | CCAHM4042E | FDA UDI | Class II | Active |
| Angled Abutment | CAA25NM4575E | FDA UDI | Class II | Active |
| Link Abutment | ICLAHM4043S | FDA UDI | Class II | Active |
| Cement Abutment | ICCAHR6042S | FDA UDI | Class II | Active |
| Healing Abutment | CHAR703 | FDA UDI | Class II | Active |
| CORE1 Fixture | C1M3511S | FDA UDI | Class II | Active |
| Milling Abutment | CMAHR5055E | FDA UDI | Class II | Active |
| Cement Abutment | CCAHR4562ES | FDA UDI | Class II | Active |
| Temporary Abutment | CTANR5595ES | FDA UDI | Class II | Active |
| Angled Abutment | ICAA25NM4072S | FDA UDI | Class II | Active |
| Solid Abutment | CSAM4563 | FDA UDI | Class II | Active |
| Temporary Abutment | CTANR6094E | FDA UDI | Class II | Active |
| Cement Abutment | ICCAHM4562ES | FDA UDI | Class II | Active |
| Cement Abutment | CCAHR4071ES | FDA UDI | Class II | Active |
| Milling Abutment | ICMAHR5073ES | FDA UDI | Class II | Active |
| Cement Abutment | ICCAHR6073ES | FDA UDI | Class II | Active |
| Angled Abutment | CAA15BR5071ES | FDA UDI | Class II | Active |
| Cement Abutment | CCAHR6065 | FDA UDI | Class II | Active |
| Solid Abutment | ICSAM4073 | FDA UDI | Class II | Active |
| Solid Abutment | CSAR4562P | FDA UDI | Class II | Active |
| Solid Abutment | CSAR5044 | FDA UDI | Class II | Active |
| Angled Abutment | CAA15AR6072E | FDA UDI | Class II | Active |
| Solid Abutment | CSAR4041 | FDA UDI | Class II | Active |
| Milling Abutment | CMANR5573ES | FDA UDI | Class II | Active |
| Angled Abutment | CAA25NR5074E | FDA UDI | Class II | Active |
| Angled Abutment | CAA15AR5572E | FDA UDI | Class II | Active |
| Angled Abutment | CAA15AR6071E | FDA UDI | Class II | Active |
| CORE1 Fixture | C1R4510O | FDA UDI | Class II | Active |
| Cement Abutment | CCANR5061E | FDA UDI | Class II | Active |
| Cement Abutment | ICCAHM4561ES | FDA UDI | Class II | Active |
| Angled Abutment | CAA25AR5073ES | FDA UDI | Class II | Active |
| Cement Abutment | CCAHR4571E | FDA UDI | Class II | Active |
| Cement Abutment | CCANR4543E | FDA UDI | Class II | Active |
| Angled Abutment | ICAA25BR5573ES | FDA UDI | Class II | Active |
| Temporary Abutment | CTAHR6094ES | FDA UDI | Class II | Active |
| Cement Abutment | CCANM4564ES | FDA UDI | Class II | Active |
| Angled Abutment | ICAA25NM4571S | FDA UDI | Class II | Active |
| Cement Abutment | ICCAHR4542ES | FDA UDI | Class II | Active |
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