FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OBTURATION GUTTA
K Number: K822464
·
Decision Nov 3, 1982
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
1
Applicant Total
5
Review Days
79
Basic Information
- Device Name
- OBTURATION GUTTA
- K Number
- K822464
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- U.S. SHIZAI CORP.
- Date Received
- August 16, 1982
- Decision Date
- November 3, 1982
- Product Code
- EKA
- 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 |
|---|---|---|---|
| EKA | File, Margin Finishing, Operative | FDA class 1 | Dental |
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