FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMTEC BIOBARRIER MEMBRANE
K Number: K972240
·
Decision Aug 26, 1997
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
30
Applicant Total
28
Review Days
71
Basic Information
- Device Name
- IMTEC BIOBARRIER MEMBRANE
- K Number
- K972240
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IMTEC CORP.
- Date Received
- June 16, 1997
- Decision Date
- August 26, 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 |
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
Other Clearances by IMTEC CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Sep 19, 2008 | Substantially Equivalent |
| K081347 | ILUMA VISION | May 28, 2008 | Substantially Equivalent |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Dec 12, 2007 | Substantially Equivalent |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | Nov 8, 2005 | Substantially Equivalent |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | Jan 13, 2005 | Substantially Equivalent |
| K042289 | MDI ORTHO | Sep 15, 2004 | Substantially Equivalent |
| K033432 | LEXATITE QUICK ACRYLIC | Jan 15, 2004 | Substantially Equivalent |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | Aug 12, 2003 | Substantially Equivalent |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Apr 23, 2003 | Substantially Equivalent |
| K024044 | SABER TECH IMPLANTS SYSTEM | Feb 21, 2003 | Substantially Equivalent |