FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIOPHIL BIPHASIC
K Number: K092788
·
Decision Dec 18, 2009
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
8
Review Days
99
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
- PERIOPHIL BIPHASIC
- K Number
- K092788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cytophil, Inc.
- Date Received
- September 10, 2009
- Decision Date
- December 18, 2009
- 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 Cytophil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K150400 | Renu Gel | Apr 6, 2015 | Substantially Equivalent |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | Feb 22, 2013 | Substantially Equivalent |
| K102937 | OSTEOPHIL BETA-TCP | Dec 27, 2010 | Substantially Equivalent |
| K093871 | PERIOPHIL B-TCP | Apr 22, 2010 | Substantially Equivalent |
| K081815 | VOCALIS GEL | Jan 5, 2009 | Substantially Equivalent |
| K081816 | VOCALIS AND VOCALIS SM | Jan 5, 2009 | Substantially Equivalent |
| K072219 | CYTOPHIL TISSUE MARKER | Jan 18, 2008 | Substantially Equivalent |