21 CFR 872.3285 — Clasp, Preformed
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3285
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EHP | Clasp, Preformed | 1 | 8 | |
| EJW | Clasp, Wire | 1 | 3 |
