Single Toot Abutment System (Sta or St Abutment ) for Single Ooth Cement Retained Restorations
by Implant Innovations, Inc. 510(k)
Active
510(k) K965077
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965077 | Date17 Mar 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The Single-Tooth Abutment System (STA or ST Abutment) is a dental implant component designed for single-tooth cement-retained restorations. Classified as a dental abutment, it connects an implant fixture to a prosthetic crown, providing a stable foundation for restoring lost natural teeth. Its primary function is to transfer occlusal forces from the restoration to the underlying implant, ensuring long-term stability and functionality. The system is tailored for use in single-tooth replacements where a cemented crown is preferred over screw-retained alternatives.
This system is supplied as a reusable, non-sterile component intended for use in clinical dental settings by trained professionals. It is not pre-sterilized but must be sterilized by the operator prior to use, adhering to standard dental sterilization protocols. The system is regulated under FDA 510K clearance (K965077) and falls under the Dental (DZE) product code, with a Substantially Equivalent (SESE) determination by the Dental (DE) Advisory Committee. No specific MRI safety classification or single-use designation is indicated in the specifications.
Other devices from Implant Innovations, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the STA abutment system used for?
The STA abutment system is specifically designed for single-tooth cement-retained restorations in dental implantology. It serves as a critical link between the implant fixture embedded in the jawbone and the prosthetic crown, ensuring stable force transfer from the crown to the implant. This design is ideal for cases where a cemented crown is preferred over screw-retained alternatives, providing a secure foundation for restoring lost natural teeth.
Is the STA abutment system reusable or single-use?
The STA abutment system is supplied as a reusable component, not intended for single-use. It is non-sterile at the time of supply and must be sterilized by the dental professional prior to clinical use. Sterilization should follow standard dental protocols to ensure safety and efficacy in the operating environment.
How should the STA abutment system be stored?
Since the STA abutment system is reusable and non-sterile, it should be stored in a clean, dry environment to prevent contamination. The packaging should remain intact until sterilization is performed. After sterilization, it should be stored in a manner that maintains sterility until immediate clinical use, adhering to dental office protocols for sterilized instruments.
What regulatory pathway does the STA abutment system follow?
The STA abutment system has obtained FDA 510K clearance under the classification K965077, with a Substantially Equivalent (SESE) determination by the Dental (DE) Advisory Committee. This means the device was reviewed and deemed equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory standards for dental implants.
Can the STA abutment system be used in MRI environments?
The provided specifications do not specify an MRI safety classification for the STA abutment system. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, particularly if the patient may require MRI imaging in the future. Always consult the manufacturer’s guidelines or additional documentation for MRI-related safety information.