21 CFR 872.3740 — Pin, Retentive And Splinting, And Accessory Instruments
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3740
Identification
A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.
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 |
|---|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 | 11 |