FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTAGEN ORAL MEMBRANE
K Number: K071555
·
Decision Aug 30, 2007
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
56
Applicant Total
12
Review Days
84
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
- FORTAGEN ORAL MEMBRANE
- K Number
- K071555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Organogenesis, Inc.
- Date Received
- June 7, 2007
- Decision Date
- August 30, 2007
- Product Code
- NPL
- 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NPL), ordered by most recent decision date.
Jason membrane
FDA 510(k)
FDA Class 2
·Dental
Augmented Gingival Matrix
FDA 510(k)
FDA Class 2
·Dental
Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
FDA 510(k)
FDA Class 2
·Dental
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
FDA 510(k)
FDA Class 2
·Dental
SwissMembrane X; SwissMembrane X Socket
FDA 510(k)
FDA Class 2
·Dental
Soft Tissue Augmentation Resorbable Matrix
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Organogenesis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212579 | FortiShield (Biosynthetic Wound Matrix) | May 2, 2023 | Substantially Equivalent |
| K220317 | PuraPly Micronized Wound Matrix (PuraPly MZ) | Jul 1, 2022 | Substantially Equivalent |
| K051647 | FORTADERM ANTIMICROBIAL WOUND DRESSING | Nov 8, 2005 | Substantially Equivalent |
| K042809 | CUFFPATCH | Nov 2, 2004 | Substantially Equivalent |
| K021107 | FORTAFLEX SURGICAL SLING | May 15, 2002 | Substantially Equivalent |
| K021105 | FORTAFLEX SURGICAL MESH | May 10, 2002 | Substantially Equivalent |
| K020049 | FORTAFLEX SURGICAL MESH | Mar 18, 2002 | Substantially Equivalent |
| K011025 | FORTAFLEX SURGICAL MESH | Aug 24, 2001 | Substantially Equivalent |
| K011026 | FORTADERM WOUND DRESSING | Jun 13, 2001 | Substantially Equivalent |
| K011027 | FORTAFLEX SURGICAL SLING | May 30, 2001 | Substantially Equivalent |