Product Code: QJX
FDA class 3
Caries Detection Product With Drug Or Biologic
Unknown
510(k)s
0
FEI Numbers
3
Registration Numbers
3
Unique Applicants
0
Years Active
—
Basic Information
- Product Code
- QJX
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- DE
- Submission Type
- 2
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.