INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH
Device Facts
| Record ID | K854765 |
|---|---|
| Device Name | INSTA-TOOTH SPLINT BAR WITH & WITHOUT TEETH |
| Applicant | C&C Systems, Inc. |
| Product Code | EHP · Dental |
| Decision Date | Jun 13, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3285 |
| Device Class | Class 1 |
Regulatory Classification
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.