← FDA Medical Device Classifications

Unit, X-Ray, Intraoral

EAP · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.1810

Classification

FDA Product Code

EAP

Device class

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

Regulation

21 CFR 872.1810

Review panel

RA

Medical specialty

Dental

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

42

Registered establishments

9

Source

Authoritative

FDA Device Classification database

Machine

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