← FDA Medical Device Classifications

Coating, Denture Hydrophilic, Resin

EBE · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3300

Classification

FDA Product Code

EBE

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 872.3300

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

3

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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