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RPM Reinforced PTFE Mesh

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K171774

by Osteogenics Biomedical, Inc.

Identity

Trade Name
RPM™ Reinforced PTFE Mesh FDA UDI
Generic Name
Dental/maxillofacial surgical mesh, metal/polymer 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
RPM200ATC 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
D765RPM200ATC0 FDA UDI
510(k) Number
K171774 FDA 510(k)FDA UDI
FDA Product Code
NPK FDA 510(k)FDA UDI
GMDN Term
Dental/maxillofacial surgical mesh, metal/polymer FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)FDA UDI
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 38 Millimeter FDA UDI
Width — 24 Millimeter FDA UDI

RPM Reinforced PTFE Mesh by Osteogenics Biomedical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Osteogenics Biomedical, Inc.

Sources (2)

  • FDA 510(k) K171774 24 fields · synced Jun 18, 2026
  • FDA UDI 24a67ebd-8f23-4473-aa43-b52e8789abfc 36 fields · synced May 22, 2026