← FDA Medical Device Classifications

Driver, Wire, And Bone Drill, Manual

DZJ · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.4120

Classification

FDA Product Code

DZJ

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 872.4120

Review panel

DE

Medical specialty

Dental

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

31

Registered establishments

48

Source

Authoritative

FDA Device Classification database

Machine

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