FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇭 Thailand
WATER FILLED TEETHER
K Number: K052105
·
Decision Oct 31, 2005
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
26
Applicant Total
1
Review Days
89
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
- WATER FILLED TEETHER
- K Number
- K052105
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5550
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Royal Industries (Thailand) Public Co. , Ltd.
- Date Received
- August 3, 2005
- Decision Date
- October 31, 2005
- Product Code
- KKO
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KKO), ordered by most recent decision date.
WATER-FILLED TEETHER
FDA 510(k)
FDA Class 2
·Dental
WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE
FDA 510(k)
FDA Class 2
·Dental
FLUID FILLED TEETHER - GEL
FDA 510(k)
FDA Class 2
·Dental
MAM COOLER
FDA 510(k)
FDA Class 2
·Dental
MAM TWISTER
FDA 510(k)
FDA Class 2
·Dental
GEL FILLED GUM SOOTHER
FDA 510(k)
FDA Class 2
·Dental