← FDA Medical Device Classifications

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EFN · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6050

Classification

FDA Product Code
EFN
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.6050
Review panel
DE
Medical specialty
Dental
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
14
Registered establishments
202

Source

Authoritative
FDA Device Classification database
Machine
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