Rfid Chip For Dental Appliance

PYQ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6300

Classification

FDA Product Code: PYQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.6300
Review panel: HO
Medical specialty: General Hospital
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown