NRQ · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3640
Classification
FDA Product Code
NRQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3640
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.