SLIP-ON FIXATION SPLINT (SFS)
Device Facts
| Record ID | K934468 |
|---|---|
| Device Name | SLIP-ON FIXATION SPLINT (SFS) |
| Applicant | Gatewood Splints |
| Product Code | EHO · Dental |
| Decision Date | Aug 5, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3165 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.
