21 CFR 872.4130 — Drill, Dental, Intraoral

Dental (DE) · Subpart E—Surgical Devices · § 872.4130

Identification

An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.

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
DZADrill, Dental, Intraoral113
Innolitics

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