← FDA Medical Device Classifications

Composite Resin Warmer

QGO · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6100

Classification

FDA Product Code
QGO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.6100
Review panel
DE
Medical specialty
Dental
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Intended to warm composite materials prior to use

Market data

Cleared 510(k) submissions
1
Registered establishments
6

Source

Authoritative
FDA Device Classification database
Machine
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