TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- TiGEN Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- TiGEN Abutment EUDAMEDCommon Ø10/ L=20/ Wide/ Non-Octa FDA UDI
- Model / Reference
- BDATGROM1220MTN EUDAMEDNOTW1020T EUDAMEDBDATGNEN1020MTN EUDAMEDBDTGNR1510T EUDAMEDNOTW1020 FDA UDI
- Description
- Common Ø10/ L=20/ Wide/ Non-Octa FDA UDI
Identifiers
- Catalog Number
- NOTW1020T FDA UDI
- Primary DI / UDI-DI
- 08806388266883 EUDAMEDFDA UDI08800292997451 EUDAMED08800292997338 EUDAMED08809931187734 EUDAMED
- Basic UDI-DI
- 880972899103PP EUDAMED
- FDA Product Code
- NHA FDA 510(k)FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The TiGEN Abutment, PMMA Abutment, and Scan Healing Abutment are dental prosthetic components designed for use with endosseous dental implants in the maxilla or mandible. These abutments serve as connectors between dental implants and prosthetic crowns, facilitating the restoration of edentulous or partially edentulous arches. The PMMA Abutment and Scan Healing Abutment feature a cuff-shaped design to ensure a precise fit with the emergence profile, enabling custom fabrication of prosthetic restorations. The TiGEN Abutment is intended for standard prosthetic rehabilitation applications in dental implantology.
These abutments are supplied as single-use components for dental implant systems and are intended for use in clinical settings by trained dental professionals. The PMMA Abutment and Scan Healing Abutment are engineered to match the contour of the emergence profile, allowing for accurate scanning and custom prosthetic fabrication. The device is authorized under FDA 510(k) clearance (K234142) and meets MDR requirements, ensuring compliance with regulatory standards for dental implant components. Storage and handling should follow standard aseptic protocols for single-use medical devices.
Frequently asked questions
What are the primary differences between the TiGEN Abutment and the PMMA/Scan Healing Abutments in terms of their design and intended use?
The TiGEN Abutment is designed for standard prosthetic rehabilitation in dental implantology, serving as a general connector between implants and crowns. In contrast, the PMMA and Scan Healing Abutments feature a cuff-shaped design that matches the emergence profile, enabling precise scanning for custom prosthetic fabrication. This makes them ideal for cases requiring tailored restorations, such as complex or individualized crowns.
Are these abutments reusable, or are they intended for single-use only?
These abutments are explicitly supplied as single-use components for clinical settings. The manufacturer emphasizes adherence to standard aseptic protocols for single-use medical devices, which aligns with best practices for infection control and patient safety in dental implantology.
How should these abutments be stored to maintain their integrity and sterility?
While the data does not specify exact storage conditions, the manufacturer advises following standard aseptic protocols for single-use medical devices. This typically includes storing in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains intact until use to preserve sterility and functionality.
What regulatory pathways have these abutments undergone, and what does that mean for their use in clinical practice?
The TiGEN Abutment, PMMA Abutment, and Scan Healing Abutment have undergone FDA 510(k) clearance (K234142) and comply with MDR (Medical Device Regulation) requirements. This means they have been evaluated for substantial equivalence to a predicate device and meet regulatory standards for safety and performance, allowing trained dental professionals to use them confidently in clinical settings.
Can these abutments be used with any dental implant system, or are they specific to certain brands?
The data does not specify compatibility with particular implant brands, but these abutments are explicitly designed for use with *endosseous dental implants* in the maxilla or mandible. For precise compatibility, it’s recommended to verify with the manufacturer or consult the product documentation, as fit and function may vary depending on the implant system’s platform or connection type.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: [PDF] Tissue friendly, Operator friendly and Patient friendly - MegaGen, TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142) — FDA ..., 510(k) Premarket Notification - FDA, PDF MegaGen Implant Co., Ltd. Hyo-Eun Lee Official Correspondent Daegu ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K234142 | Class II | Active |
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Manufacturer
- Manufacturer
- Megagen Implant Co., Ltd.
Sources (6)
- FDA 510(k) K234142 24 fields · synced Sep 30, 2026
- FDA UDI b570192a-b9e8-4b71-b838-c8c6c7c29782 35 fields · synced May 30, 2026
- EUDAMED 063e60c8-863f-4a3a-9f1a-99255afa5079 61 fields · synced Aug 1, 2026
- EUDAMED 0c07be9e-84af-46e2-ac30-c56a7c40dbbb 61 fields · synced Aug 1, 2026
- EUDAMED d1ddb3b3-2bb3-4ce2-b380-23c9691c6ce0 61 fields · synced Sep 17, 2026
- EUDAMED 8113edaf-9c90-431a-958e-29c5c4b70d5c 61 fields · synced Sep 30, 2026