Dental Implants OKTAGON Bone Level Tapered Design
by Hager& Meisinger GmbH 510(k)
Active
510(k) K170287
Overview
The Dental Implants OKTAGON Bone Level Tapered Design is a bone-level dental implant system designed for osseointegration in the alveolar ridge. Its tapered geometry and bone-level platform placement facilitate stable integration with surrounding bone, supporting long-term prosthetic restoration. The tapered design enhances primary stability during placement while maintaining a consistent crestal bone level for predictable outcomes. This implant is categorized under dental implant systems with a focus on bone-level integration, as defined by regulatory classifications.
This implant is supplied sterile and intended for single-use in oral and maxillofacial surgical procedures. It is classified under product code DZE and has received FDA 510(k) clearance as substantially equivalent to predicate devices. The tapered design and bone-level platform are engineered to minimize soft tissue irritation and optimize prosthetic access. Storage requires adherence to sterile packaging instructions, and compatibility with standard dental imaging and MRI protocols must be verified prior to use. No additional regulatory approvals beyond the stated FDA_510K are implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170287 | Date24 May 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hager& Meisinger GmbH
Questions
What is the OKTAGON Bone Level Tapered Design implant used for?
This implant is designed specifically for osseointegration in the alveolar ridge, providing stable integration with surrounding bone to support long-term prosthetic restorations. The tapered geometry and bone-level platform placement help maintain crestal bone levels, ensuring predictable outcomes for patients undergoing dental implant procedures.
How is the OKTAGON Bone Level Tapered Design implant supplied and intended for use?
The implant is supplied sterile and is intended for single-use only in oral and maxillofacial surgical procedures. This ensures patient safety and maintains the integrity of the implant’s design for optimal performance during placement.
Is the OKTAGON Bone Level Tapered Design implant reusable?
No, this implant is explicitly designed for single-use. Reusing it could compromise sterility, stability, and the integrity of the tapered design, potentially leading to complications during osseointegration or prosthetic restoration.
What storage instructions apply to the OKTAGON Bone Level Tapered Design?
The implant must be stored strictly according to the sterile packaging instructions provided by the manufacturer. Proper storage ensures the implant remains uncontaminated and ready for use, preserving its performance and safety for surgical procedures.
Does the OKTAGON Bone Level Tapered Design require any special considerations for imaging or MRI?
Before use, compatibility with standard dental imaging and MRI protocols should be verified. While the implant is designed for clinical use, its material properties may interact with imaging equipment, so clinicians should confirm safety and accuracy prior to scanning.