FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUCOGRAFT
K Number: K102531
·
Decision Nov 17, 2010
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
2
Review Days
75
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Basic Information
- Device Name
- MUCOGRAFT
- K Number
- K102531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ed. Geistlich Soehne AG Fur Chemische Industrie
- Date Received
- September 3, 2010
- Decision Date
- November 17, 2010
- Product Code
- NPL
- 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
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Other Clearances by Ed. Geistlich Soehne AG Fur Chemische Industrie
| K Number | Device Name | ||
|---|---|---|---|
| K090401 | ORTHOSS | Jan 8, 2010 | Substantially Equivalent |