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EJI · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.6770

Classification

FDA Product Code
EJI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.6770
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
45
Registered establishments
73

Source

Authoritative
FDA Device Classification database
Machine
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