EJW · Clasp, Wire
Dental · 21 CFR 872.3285 · Class 1
Overview
| Product Code | EJW |
|---|---|
| Device Name | Clasp, Wire |
| Regulation | 21 CFR 872.3285 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.
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 |
|---|---|---|---|---|
| K901257 | WIRONTOM CLASP WIRE | Ivoclar North America, Inc. | Apr 25, 1990 | SESE |
| K881331 | ORTHODONTIC NITINOL SPRINGS | Flexmedics | Apr 21, 1988 | SESE |
| K872746 | VITALLIUM WIRE | Austenal Dental, Inc. | Jul 21, 1987 | SESE |
Top Applicants
- Ivoclar North America, Inc. — 1 clearance
- Flexmedics — 1 clearance
- Austenal Dental, Inc. — 1 clearance
