FDA.reportPublic FDA data

RPM™ Reinforced PTFE Mesh

Primary DI
D765RPM200K20
Brand
RPM™ Reinforced PTFE Mesh
Company
Osteogenics Biomedical Inc
Model
RPM200K2
Device 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.
Published
2020-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPKBarrier, Synthetic, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171774000RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.2017-10-19NPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D765RPM200K20PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical meshAn implantable, non-bioabsorbable, woven/knitted porous material made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE)] intended to temporarily provide stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Width40Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
123853058
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D765CS0523BK0Cytoplast™ PTFE SutureCS0523BK2019-02-22
D765RPM200ATCM0RPM™ Reinforced PTFE MeshRPM200ATCM2020-07-27
D765GC3019450X-Gut™ Chromic Gut SutureGC3019452025-09-01
D765GC3019750X-Gut™ Chromic Gut SutureGC3019752025-09-01
D765GC3019P450X-Gut™ Chromic Gut SutureGC3019P452025-09-01
D765GC3019P750X-Gut™ Chromic Gut SutureGC3019P752025-09-01
D765GC4013P450X-Gut™ Chromic Gut SutureGC4013P452025-09-01
D765GC4019450X-Gut™ Chromic Gut SutureGC4019452025-09-01
D765GC4019750X-Gut™ Chromic Gut SutureGC4019752025-09-01
D765GC4019P450X-Gut™ Chromic Gut SutureGC4019P452025-09-01
D765GC5013P450X-Gut™ Chromic Gut SutureGC5013P452025-09-01
D765GC5016P450X-Gut™ Chromic Gut SutureGC5016P452025-09-01
D765GC5019450X-Gut™ Chromic Gut SutureGC5019452025-09-01
D765GP3019450X-Gut™ Plain Gut SutureGP3019452025-09-01
D765GP3019750X-Gut™ Plain Gut SutureGP3019752025-09-01
D765GP3022450X-Gut™ Plain Gut SutureGP3022452025-09-01
D765GP3024750X-Gut™ Plain Gut SutureGP3024752025-09-01
D765GP4019450X-Gut™ Plain Gut SutureGP4019452025-09-01
D765GP4019750X-Gut™ Plain Gut SutureGP4019752025-09-01
D765GC3019451X-Gut™ Chromic Gut SutureGC3019452025-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841336100206Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
00841336100213Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
08800016105865InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2025-10-14
08800039006682TBS PTFE membranePURGO BIOLOGICS Inc.NPK2025-07-24
D767C0609010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0613010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0617010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0635010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0639010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0641010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
08800016107135InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107142InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107159InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107166InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107173InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107180InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107241InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107258InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016108002InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144963InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144987InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144994InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726370InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726387InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726394InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726400InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
D767C0501010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0503010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0505010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0507010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10