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 CodeDevice NameClassDevicesAttributes
EBLPin, Retentive And Splinting, And Accessory Instruments111
Innolitics

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