← FDA Medical Device Classifications

Cleaner, Denture, Mechanical

JER · Class I — Low Risk (general controls) · Dental · 21 CFR 872.3530

Classification

FDA Product Code

JER

Device class

Class I — Low Risk (general controls)

Regulation

21 CFR 872.3530

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

14

Registered establishments

30

Source

Authoritative

FDA Device Classification database

Machine

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