FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
LuxCreo Dental Night Guard Resin
K Number: K230592
·
Decision Jan 18, 2024
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
4
Review Days
321
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LuxCreo Dental Night Guard Resin
- K Number
- K230592
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LuxCreo, Inc.
- Date Received
- March 3, 2023
- Decision Date
- January 18, 2024
- Product Code
- MQC
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQC), ordered by most recent decision date.
UltraPrint-Dental Hard Splint UV
FDA 510(k)
FDA Unclassified
·Unknown
Remvia NightGuard
FDA 510(k)
FDA Unclassified
·Unknown
NOBILCAM IMPAK Disc
FDA 510(k)
FDA Unclassified
·Unknown
Hard Splint & Thermo-Adaptive Splint
FDA 510(k)
FDA Unclassified
·Unknown
Remi Custom Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
LIJIA Night Guard
FDA 510(k)
FDA Unclassified
·Unknown