FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PDI PARALLEL SIDED POST KIT
K Number: K913019
·
Decision Oct 2, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
2
Review Days
85
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Basic Information
- Device Name
- PDI PARALLEL SIDED POST KIT
- K Number
- K913019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Precident Corp.
- Date Received
- July 9, 1991
- Decision Date
- October 2, 1991
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
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Other Clearances by Precident Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K911323 | FLUX-N-ALL | Sep 30, 1991 | Substantially Equivalent |