FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARTICULATING PAPER
K Number: K832647
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
9
Applicant Total
3
Review Days
200
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Basic Information
- Device Name
- ARTICULATING PAPER
- K Number
- K832647
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6140
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ardent Intl., Inc.
- Date Received
- August 5, 1983
- Decision Date
- February 21, 1984
- Product Code
- EFH
- 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 |
|---|---|---|---|
| EFH | Paper, Articulation | FDA class 1 | Dental |
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