Healing Abutment System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Healing Abutment System EUDAMED
- Model / Reference
- TSHAL455M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800271278090 EUDAMED
- Basic UDI-DI
- 88000406CSHAKX EUDAMED
- 510(k) Number
- K251434 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Market of Registration
- Czechia EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
The Healing Abutment System is a dental implant component designed to facilitate osseointegration and soft tissue healing around dental implants. It serves as an intermediary between the implant fixture and the final prosthetic restoration, ensuring proper alignment and stability during the healing phase.
This system is supplied sterile and intended for single-use in dental clinical settings. It is classified under the product code NHA and has received FDA 510K clearance as substantially equivalent to a predicate device, along with MDR authorization. Sizes and configurations are specified in the manufacturer’s documentation, adhering to dental implant standards for biocompatibility and mechanical integrity.
Frequently asked questions
What is the primary purpose of the Healing Abutment System in dental implant procedures?
The Healing Abutment System acts as a critical intermediary between the dental implant fixture and the final prosthetic restoration. Its main role is to support osseointegration—the process where bone grows around the implant—and to guide soft tissue healing, ensuring proper alignment and stability during the healing phase. This helps create a strong foundation for the eventual crown or bridge.
Is the Healing Abutment System intended for reuse in clinical settings, or is it designed for single-use?
The Healing Abutment System is explicitly designed for single-use in dental clinical settings. This is a standard practice for implant components to maintain sterility and reduce the risk of cross-contamination, ensuring patient safety and optimal outcomes.
How is the Healing Abutment System supplied, and what does this mean for handling in the clinic?
The system is supplied sterile, meaning it is pre-sterilized and packaged to prevent contamination before use. Clinicians should follow the manufacturer’s instructions for opening and handling to preserve sterility, as improper handling could compromise the device’s integrity or patient safety.
What regulatory pathways has the Healing Abutment System undergone, and what does this indicate about its approval status?
The device has received FDA 510K clearance under the *Traditional* pathway, determined to be *substantially equivalent* to a predicate device, and it also holds MDR authorization. This means it has undergone regulatory review to confirm safety, performance, and compliance with dental implant standards before market entry.
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.
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 | K251434 | Class II | Active |
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Manufacturer
- Manufacturer
- Osstem Implant Co., Ltd.
Sources (2)
- FDA 510(k) K251434 24 fields · synced Sep 18, 2026
- EUDAMED a724306d-ed1e-47c4-a522-444f89cb921e 61 fields · synced Jul 22, 2026