Caries Detection Product With Drug Or Biologic

QJX · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: QJX
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: DE
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

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