FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SEPTOPACK
K Number: K830113
·
Decision May 9, 1983
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
11
Review Days
118
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Basic Information
- Device Name
- SEPTOPACK
- K Number
- K830113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- North Pacific Dental, Inc.
- Date Received
- January 11, 1983
- Decision Date
- May 9, 1983
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by North Pacific Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830111 | SEPTOCAL | Mar 24, 1983 | Substantially Equivalent |
| K830106 | UNICIDE | Mar 7, 1983 | Substantially Equivalent |
| K830109 | CIMPAT | Mar 1, 1983 | Substantially Equivalent |
| K830115 | PAPER POINTS | Mar 1, 1983 | Substantially Equivalent |
| K830117 | ENDOMET | Mar 1, 1983 | Substantially Equivalent |
| K830105 | VITATHYL | Mar 1, 1983 | Substantially Equivalent |
| K830114 | GUTTA PERCHA POINTS | Mar 1, 1983 | Substantially Equivalent |
| K830107 | SELFAST | Feb 18, 1983 | Substantially Equivalent |
| K830116 | SULCARINGS | Feb 18, 1983 | Substantially Equivalent |
| K830112 | HYDROL | Feb 18, 1983 | Substantially Equivalent |