Identifiers
- 510(k) Number
- K110425 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HC-BIOS Dental Implant is a dental implant device designed for osseointegration within the alveolar bone to support dental prostheses. Classified under product code DZE, it is intended for use in dental procedures requiring stable, long-term integration with the jawbone, facilitating the restoration of missing teeth. Constructed from titanium, it adheres to standards for biocompatibility and structural integrity in oral applications. This implant system is engineered to provide a foundation for crowns, bridges, or other dental restorations, ensuring functional and aesthetic outcomes for patients.
This implant is supplied as a sterile, single-use device, intended for surgical placement by trained dental professionals in clinical settings. It is regulated under FDA 510(k) clearance (K110425) as substantially equivalent to predicate devices, adhering to traditional review pathways. The device is manufactured under GMP and ISO 13485 quality assurance systems, ensuring compliance with international standards for medical implants. No MRI safety information is specified, and storage conditions are not detailed in the provided data, though typical sterile implant handling practices apply.
Frequently asked questions
What is the HC-BIOS Dental Implant designed for?
The HC-BIOS Dental Implant is specifically designed for osseointegration within the alveolar bone to serve as a stable foundation for dental prostheses. This includes crowns, bridges, or other restorations, ensuring both functional and aesthetic outcomes for patients with missing teeth. Its titanium construction ensures biocompatibility and structural integrity in oral environments.
How is the HC-BIOS Dental Implant supplied and intended for use?
The HC-BIOS Dental Implant is supplied as a sterile, single-use device. It is intended exclusively for surgical placement by trained dental professionals in clinical settings. This ensures proper handling and minimizes risks associated with contamination or reuse.
Is the HC-BIOS Dental Implant reusable or single-use?
The HC-BIOS Dental Implant is explicitly designed for single-use only. This is a standard practice for dental implants to maintain sterility and reduce infection risks during surgical procedures. Reuse is not recommended or supported by the manufacturer.
What regulatory approvals does the HC-BIOS Dental Implant hold?
The HC-BIOS Dental Implant has received FDA 510(k) clearance under the reference number K110425. This clearance is based on a determination of substantial equivalence to predicate devices, following traditional review pathways. The implant also adheres to GMP and ISO 13485 quality assurance standards.
Are there any specific storage instructions for the HC-BIOS Dental Implant?
The provided data does not specify detailed storage conditions for the HC-BIOS Dental Implant. However, as a sterile medical device, it should be stored in accordance with typical sterile implant handling practices to preserve its integrity and sterility until use. This generally includes protection from moisture, contamination, and physical damage.
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: MEDICAL TAIWAN-Exhibitor Info.-HUNG CHUN BIO-S CO., LTD., PDF 鴻君科技股份有限公司 | Hung Chun Bio-S Tech, HUNG CHUN BIO-S CO., LTD. | Taiwantrade, Hung Chun Bio-S Co., Ltd: Contact Details and Business Profile
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110425 | Class II | Active |
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Manufacturer
- Manufacturer
- Hung Chun Bio-S Co., Ltd.
Sources (1)
- FDA 510(k) K110425 24 fields · synced Oct 1, 2026