EHO · Bar, Preformed
Dental · 21 CFR 872.3165 · Class 1
Overview
| Product Code | EHO |
|---|---|
| Device Name | Bar, Preformed |
| Regulation | 21 CFR 872.3165 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934468 | SLIP-ON FIXATION SPLINT (SFS) | Gatewood Splints | Aug 5, 1994 | SESE |
| K881133 | 70-X/RVG (RADIOVISIOGRAPHY) | Trophy Radiologie | Jul 20, 1989 | SESE |
| K883388 | DENTREK BRIDGE BARS | Dale T. Dupuis | Oct 6, 1988 | SESE |
Top Applicants
- Trophy Radiologie — 1 clearance
- Gatewood Splints — 1 clearance
- Dale T. Dupuis — 1 clearance
