510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QJXClass III

Caries Detection Product With Drug Or Biologic

Unknown
FDA source (opens on fda.gov)

QJX is the FDA product code for Caries Detection Product With Drug Or Biologic, a class III device type. FDA's definition for this code reads: "Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QJX
Device name
Caries Detection Product With Drug Or Biologic
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code