FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDOR BIORESORBABLE MATRIX BARRIER
K Number: K132325
·
Decision Oct 29, 2013
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
30
Applicant Total
3
Review Days
95
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
- GUIDOR BIORESORBABLE MATRIX BARRIER
- K Number
- K132325
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sunstar Americas, Inc.
- Date Received
- July 26, 2013
- Decision Date
- October 29, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPK), ordered by most recent decision date.
Lumina-PTFE Titanium
FDA 510(k)
FDA Class 2
·Dental
OpenTex
FDA 510(k)
FDA Class 2
·Dental
InnoGenic Non-resorbable Membrane
FDA 510(k)
FDA Class 2
·Dental
Bio-MEM Ti Reinforced Membrane
FDA 510(k)
FDA Class 2
·Dental
Cytoplast Titanium-Reinforced PTFE Membranes
FDA 510(k)
FDA Class 2
·Dental
RPM Reinforced PTFE Mesh
FDA 510(k)
FDA Class 2
·Dental