← FDA Medical Device Classifications

Crown And Bridge, Temporary, Resin

EBG · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3770

Classification

FDA Product Code
EBG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3770
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
189
Registered establishments
180

Source

Authoritative
FDA Device Classification database
Machine
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