Clasp, Wire
The Wire Clasp is a dental component made of wrought wire bent and shaped to form a retentive clasp on a removable partial denture, engaging the undercut of an abutment tooth to secure the prosthesis in place. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJW, regulated under 21 CFR 872.3285 in the Dental (DE) specialty.
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Basic Information
- Product Code
- EJW
- Device Class
- FDA class 1
- Regulation Number
- 872.3285
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901257 | WIRONTOM CLASP WIRE | Apr 25, 1990 | Substantially Equivalent | Ivoclar North America, Inc. |
| K881331 | ORTHODONTIC NITINOL SPRINGS | Apr 21, 1988 | Substantially Equivalent | Flexmedics |
| K872746 | VITALLIUM WIRE | Jul 21, 1987 | Substantially Equivalent | Austenal Dental, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.