FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇸🇪 Sweden
GUIDOR(TM)
K Number: K912724
·
Decision May 13, 1993
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
1
Review Days
695
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Basic Information
- Device Name
- GUIDOR(TM)
- K Number
- K912724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Procordia Oratech AB
- Date Received
- June 18, 1991
- Decision Date
- May 13, 1993
- Product Code
- NPK
- 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
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