← FDA Medical Device Classifications

Tray, Impression, Preformed

EHY · Class I — Low Risk (general controls) · Dental · 21 CFR 872.6880

Classification

FDA Product Code
EHY
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.6880
Review panel
DE
Medical specialty
Dental
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
16
Registered establishments
312

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown