← FDA Medical Device Classifications

Instrument, Cutting, Operative

EKD · Class I — Low Risk (general controls) · Dental · 21 CFR 872.4565

Classification

FDA Product Code

EKD

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 872.4565

Review panel

DE

Medical specialty

Dental

Submission type

4

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

2

Registered establishments

70

Source

Authoritative

FDA Device Classification database

Machine

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