BHDental Implant System
510(k) K103280
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103280 | Date24 Feb 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3630
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The BHDental Implant System is a dental implant device classified as an endosseous root-form implant system, including one- and two-stage implants, cover screws, healing caps, abutment systems, and superstructures. It provides osseointegrated support for prosthetic dental restorations, featuring internal/external hexagonal or internal octagonal connections for stability. Designed for surgical and restorative dental procedures, it facilitates the placement of artificial teeth and related prosthetic components.
This system is intended for use in dental clinics and oral surgery settings, supplied as a sterile or non-sterile kit depending on the components. The implants are reusable for single-patient use per manufacturer guidelines, with sizes and configurations detailed in the product specifications. Authorized under FDA 510(k) clearance (K103280) as a Class II device under the NHA product code, it adheres to dental implant standards for abutments and prosthetic components. Storage and handling follow standard aseptic protocols for surgical implants.
Questions
AI-generated answers, 1 Oct 2026
What types of dental implants does the BHDental Implant System include?
The BHDental Implant System includes one- and two-stage endosseous root-form implants, along with cover screws, healing caps, abutment systems, and superstructures. These components work together to provide osseointegrated support for prosthetic dental restorations, ensuring stability through internal/external hexagonal or internal octagonal connections.
How is the BHDental Implant System supplied, and what are its sterility options?
The BHDental Implant System is supplied as either sterile or non-sterile kits, depending on the specific components included. Sterility is critical for surgical use, and the manufacturer provides guidelines to ensure proper handling and storage to maintain aseptic conditions, particularly for reusable implants intended for single-patient use.
Are the implants reusable, and if so, how should they be handled?
Yes, the BHDental Implant System implants are reusable for single-patient use as per manufacturer guidelines. To ensure safety and compliance with surgical standards, they must be handled and stored under strict aseptic protocols. This includes proper cleaning, sterilization (if applicable), and storage in a clean, dry environment to prevent contamination before use.
What connection types does the BHDental Implant System use for stability?
The system features internal/external hexagonal connections and internal octagonal connections to enhance stability during osseointegration. These connection types help secure the implant to the abutment and superstructure, reducing the risk of loosening or failure over time.
Where can the BHDental Implant System be used, and what regulatory clearance does it hold?
The BHDental Implant System is intended for use in dental clinics and oral surgery settings for surgical and restorative dental procedures. It holds FDA 510(k) clearance (K103280) as a Class II device under the NHA product code, meeting dental implant standards for abutments and prosthetic components.