FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
INION GTR BIODEGRADABLE MEMBRANE SYSTEM
K Number: K033074
·
Decision Mar 31, 2004
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
23
Review Days
184
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Basic Information
- Device Name
- INION GTR BIODEGRADABLE MEMBRANE SYSTEM
- K Number
- K033074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inion , Ltd.
- Date Received
- September 29, 2003
- Decision Date
- March 31, 2004
- 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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| K050275 | MODIFICATION TO: INION OTPS BIODEGRADABLE PIN | Mar 7, 2005 | Substantially Equivalent |
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