FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL MOUTHPROP (BITE BLOCK)
K Number: K792157
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
2
Review Days
15
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
- DENTAL MOUTHPROP (BITE BLOCK)
- K Number
- K792157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5070
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Mission Dental, Inc.
- Date Received
- October 29, 1979
- Decision Date
- November 13, 1979
- Product Code
- JXL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXL | Block, Bite | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXL), ordered by most recent decision date.
PATI (Protector Against Tongue Injury)
FDA 510(k)
FDA Class 2
·Neurology
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
FDA 510(k)
FDA Class 2
·Neurology
SurgeoBite
FDA 510(k)
FDA Class 2
·Neurology
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
FDA 510(k)
FDA Class 2
·Neurology
EPIGUARD
FDA 510(k)
FDA Class 2
·Neurology
VENTIL-A ORAL PROTECTOR
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Mission Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832752 | COMFORT CUSHION DISPOS. ANALGESIS | Dec 8, 1983 | Substantially Equivalent |