SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
Device Facts
| Record ID | K240531 |
|---|---|
| Device Name | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment |
| Applicant | BioHorizons Implant Systems, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Jul 30, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
