Identity
- Trade Name
- RPM™ Reinforced PTFE Mesh FDA UDI
- Generic Name
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
- Device Name
- RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites. FDA UDI
- Model / Reference
- RPM250BL FDA UDI
- Description
- RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D765RPM250BLM20 FDA UDI
- 510(k) Number
- K171774 FDA UDI
- FDA Product Code
- NPK FDA UDI
- GMDN Term
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Width — 17 Millimeter FDA UDILength — 25 Millimeter FDA UDI
RPM™ Reinforced PTFE Mesh by Osteogenics Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K171774 also covers:
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
- RPM™ Reinforced PTFE Mesh — OSTEOGENICS BIOMEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Osteogenics Biomedical, Inc.
Sources (1)
- FDA UDI ef23011d-927f-495f-abec-1bb520545fee 37 fields · synced Jun 8, 2026