FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTA MAXIGRO AND REGIGRO
K Number: K091424
·
Decision Aug 18, 2010
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
1
Review Days
462
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Basic Information
- Device Name
- OSTA MAXIGRO AND REGIGRO
- K Number
- K091424
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osta Technologies
- Date Received
- May 13, 2009
- Decision Date
- August 18, 2010
- Product Code
- NPM
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
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