FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-GIDE RESORBABLE BILAYER MEMBRANE
K Number: K960724
·
Decision Jun 11, 1997
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
16
Review Days
475
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Basic Information
- Device Name
- BIO-GIDE RESORBABLE BILAYER MEMBRANE
- K Number
- K960724
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Geistlich-Pharma
- Date Received
- February 22, 1996
- Decision Date
- June 11, 1997
- Product Code
- NPK
- 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 |
|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | FDA class 2 | Dental |
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Other Clearances by Geistlich-Pharma
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|---|---|---|---|
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| K970569 | BIO-BLOCKS | Aug 14, 2000 | Substantially Equivalent |
| K974399 | BIO-OSS COLLAGEN | Sep 16, 1998 | Substantially Equivalent |
| K970321 | BIO-OSS ANORGANIC BOVINE BONE | Sep 15, 1998 | Substantially Equivalent |
| K972817 | RESOR-PIN RESORBABLE MEMBRANE PIN | Jul 24, 1998 | Substantially Equivalent |
| K952619 | BIO-OSS CERAMIC | Aug 28, 1995 | Substantially Equivalent |
| K952618 | BIO-OSS | Aug 28, 1995 | Substantially Equivalent |
| K952617 | BIO-OSS | Aug 7, 1995 | Substantially Equivalent |
| K920508 | BIO-OSS BLOCKS | Nov 24, 1992 | Substantially Equivalent |