FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
K Number: K873763
·
Decision Dec 8, 1987
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
16
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIO-OSS - CERAMIC PURE NATURAL HYDROXYAPATITE
- K Number
- K873763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Geistlich-Pharma
- Date Received
- September 16, 1987
- Decision Date
- December 8, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.
Bonalive Maxillofacial
FDA 510(k)
FDA Class 2
·Dental
BONTREE PLUS
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft M
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft B
FDA 510(k)
FDA Class 2
·Dental
Synthetic Bone Graft Particulate
FDA 510(k)
FDA Class 2
·Dental
CMFlexTM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Geistlich-Pharma
| K Number | Device Name | ||
|---|---|---|---|
| K033815 | BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN | Jan 15, 2004 | Substantially Equivalent |
| K014289 | ORTHOSS RESORBABLE BONE VOID FILLER | Mar 28, 2002 | 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 |