QRY · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.4120
Classification
FDA Product Code
QRY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.4120
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures.