FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PLANUSTAR AND DENS NOBILIS DENTURE TEETH
K Number: K912989
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
3
Applicant Total
16
Review Days
39
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Basic Information
- Device Name
- PLANUSTAR AND DENS NOBILIS DENTURE TEETH
- K Number
- K912989
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wilde-USA, Inc.
- Date Received
- July 8, 1991
- Decision Date
- August 16, 1991
- Product Code
- EMI
- 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 |
|---|---|---|---|
| EMI | File, Bone, Surgical | FDA class 1 | Dental |
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