Identifiers
- 510(k) Number
- K150388 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)
A dental implant system is a device used to replace missing teeth by providing a foundation for prosthetic teeth. It is substantially equivalent to legally marketed devices and has been reviewed by the Dental advisory committee.
The device is supplied by Bio Concept Co., Ltd. and was cleared via the traditional 510(k) pathway under K150388. It is authorized for use in dental applications and is not MRI conditional or sterile unless otherwise specified in labeling.
Frequently asked questions
What is the Dental Implant System used for?
The Dental Implant System is used to replace missing teeth by providing a stable foundation for prosthetic teeth, such as crowns or bridges, restoring both function and appearance in dental applications.
How is the Dental Implant System supplied and is it sterile?
The device is supplied by Bio Concept Co., Ltd. and is not sterile unless otherwise specified in the labeling; users must consult the product labeling for specific sterility information before use.
What regulatory pathway was used for the Dental Implant System clearance?
The Dental Implant System was cleared via the traditional 510(k) pathway under K150388, demonstrating substantial equivalence to legally marketed predicate devices as determined by FDA review.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150388 | Class II | Active |
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Manufacturer
- Manufacturer
- BIO CONCEPT Co., Ltd.
Sources (1)
- FDA 510(k) K150388 24 fields · synced Sep 23, 2026