Cytoflex Ti-enforced

Primary DI
D767C0509010
Brand
Cytoflex Ti-enforced
Company
UNICARE BIOMEDICAL INC.
Model
19x26mm
Catalog number
C05-0901
Device description
Ti-Enforced® ePTFE membranes are a multi-layer, non-resorbable membrane intended to be surgically placed under the muco-periosteum to aid in tissue regeneration in accordance with the guided tissue regeneration principle. It is a barrier material with a titanium frame enclosed within two layers of ePTFE material. The titanium reinforcement is intended for space and shape maintenance to contain bone grafting material and to minimize graft movement during wound healing. The membranes are designed to block bacteria penetration, and impede the migration and establishment of gingival tissue derived cells into bony defects. This provides a more favorable environment for neovascularization and for bone derived cells to repopulate and repair the defect. The Ti-Enforced® membranes are textured on both surfaces to improve handling and adhesion between tissue and membrane.
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K151344000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151344000Cytoflex Tefguard Ti-Enforced MembraneUnicare Biomedical, Inc.2015-11-19NPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D767C0509010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pliable-polymer dental regeneration membrane, non-bioabsorbableA sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged.
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
949-305-9600sales@unicarebiomedical.com

Regulatory Flags#

DUNS number
038023573
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D767C0701010CollaFlex15mm x 20mmC07-01012024-01-10
D767C0702010CollaFlex20mm x 30mmC07-02012024-01-10
D767C0703010CollaFlex30mm x 40mmC07-03012024-01-10
D767B0205101Benacel Plus5x5cmB02-05102024-07-12
D767B0210101Benacel Plus5x10cmB02-10102024-07-12
D767B0214101Benacel Plus5x20cmB02-14102024-07-12
D767B0222101Benacel Plus10x10cmB02-22102024-07-12
D767B0224101Benacel Plus10x15mmB02-24102024-07-12
D767B0226101Benacel Plus10x20mmB02-26102024-07-12
D767C0609010Perforated Cytoflex Ti-enforced19x26mmC06-09012024-07-12
D767C0613010Perforated Cytoflex Ti-enforced20x25mmC06-13012024-07-12
D767C0617010Perforated Cytoflex Ti-enforced25x30mmC06-17012024-07-12
D767C0635010Perforated Cytoflex Ti-enforced25x36mmC06-35012024-07-12
D767C0639010Perforated Cytoflex Ti-enforced30x41mmC06-39012024-07-12
D767C0641010Perforated Cytoflex Ti-enforced32x40mmC06-41012024-07-12
D767C0801010Perforated Tefguard12x24mmC08-01012024-07-12
D767C0802010Perforated Tefguard25x30mmC08-02012024-07-12
D767C0501010Cytoflex Ti-enforced13x20mmC05-01012024-01-10
D767C0503010Cytoflex Ti-enforced12x24mmC05-03012024-01-10
D767C0505010Cytoflex Ti-enforced14x24mmC05-05012024-01-10

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
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