FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OBTURATION SYSTEM KIT
K Number: K820639
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
5
Review Days
32
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
- OBTURATION SYSTEM KIT
- K Number
- K820639
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- U.S. Shizai Corp.
- Date Received
- March 8, 1982
- Decision Date
- April 9, 1982
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKM), ordered by most recent decision date.
EI DOWNPAK BARRIER SLEEVES
FDA 510(k)
FDA Class 1
·Dental
DOWN PAK
FDA 510(k)
FDA Class 1
·Dental
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
FDA 510(k)
FDA Class 1
·Dental
ENDO TWINN
FDA 510(k)
FDA Class 1
·Dental
FIBERFILL SGP
FDA 510(k)
FDA Class 1
·Dental
ANTIBACTERIAL GUTTA PERCHA
FDA 510(k)
FDA Class 1
·Dental