FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOSS RESORBABLE BONE VOID FILLER
K Number: K014289
·
Decision Mar 28, 2002
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
16
Review Days
90
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Basic Information
- Device Name
- ORTHOSS RESORBABLE BONE VOID FILLER
- K Number
- K014289
- 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
- December 28, 2001
- Decision Date
- March 28, 2002
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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Other Clearances by Geistlich-Pharma
| K Number | Device Name | ||
|---|---|---|---|
| K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN | Jan 15, 2004 | Substantially Equivalent |
| 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 |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Jun 11, 1997 | 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 |