Product code PFL

Device name
Intraoral, Dental Foam Protector
Medical specialty
Dental
Device class
1
Regulation number
872.6890
Review panel
DE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Source
FDA openFDA device classification dataset