FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOTAPE
K Number: K090794
·
Decision Dec 10, 2009
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
5
Review Days
261
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Basic Information
- Device Name
- OSTEOTAPE
- K Number
- K090794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Impladent , Ltd.
- Date Received
- March 24, 2009
- Decision Date
- December 10, 2009
- 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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Other Clearances by Impladent , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K141764 | TRISTAR BONE GRAFT FIXATION SYSTEM | Dec 18, 2014 | Substantially Equivalent |
| K033098 | OSTEOGEN SBRG | Apr 27, 2004 | Substantially Equivalent |
| K982925 | LAMINOSS DENTAL IMPLANT | May 18, 1999 | Substantially Equivalent |
| K933705 | LAMINOSS DENTAL IMPLANT | Jun 24, 1996 | Substantially Equivalent |