FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-OSS COLLAGEN
K Number: K092428
·
Decision Mar 18, 2010
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
6
Review Days
223
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Basic Information
- Device Name
- BIO-OSS COLLAGEN
- K Number
- K092428
- 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 Fuer Chemische Industrie
- Date Received
- August 7, 2009
- Decision Date
- March 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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Other Clearances by Ed. Geistlich Soehne AG Fuer Chemische Industrie
| K Number | Device Name | ||
|---|---|---|---|
| K073711 | MUCOGRAFT COLLAGEN MATRIX | May 30, 2008 | Substantially Equivalent |
| K061244 | MUCOGRAFT | Jun 6, 2006 | Substantially Equivalent |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE | Aug 9, 2005 | Substantially Equivalent |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION | Nov 15, 2004 | Substantially Equivalent |
| K012423 | MUCOGRAFT | Jan 24, 2003 | Substantially Equivalent |