FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K Number: K050446
·
Decision Aug 9, 2005
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
6
Review Days
168
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Basic Information
- Device Name
- BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
- K Number
- K050446
- 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
- February 22, 2005
- Decision Date
- August 9, 2005
- 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 Fuer Chemische Industrie
| K Number | Device Name | ||
|---|---|---|---|
| K092428 | BIO-OSS COLLAGEN | Mar 18, 2010 | Substantially Equivalent |
| K073711 | MUCOGRAFT COLLAGEN MATRIX | May 30, 2008 | Substantially Equivalent |
| K061244 | MUCOGRAFT | Jun 6, 2006 | 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 |