FDA.reportPublic FDA data

Cytoflex Resorb

Primary DI
D767C0301010
Brand
Cytoflex Resorb
Company
UNICARE BIOMEDICAL INC.
Model
30x40mm
Catalog number
C03-0101
Device description
Cytoflex® Resorb is a synthetic, microporous resorbable barrier membrane. Cytoflex® Resorb membranes are designed to enhance the adhesion of host cells, and at the same time provide a favorable environment for neo-vascularization and repopulation of bone cells to regenerate osseous tissue. The flexible barrier membranes are easily adaptable to tissue contours, yet offer sufficient duration to protect the bony defect from the intrusion of bacteria and soft tissue. Composed of synthetic polylactide and polyglycolide copolymers, Cytoflex® Resorb barriers are resorbable and do not require a second retrieval procedure.
Published
2015-09-24
Public version status
Update
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
K090083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090083000CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090Unicare Biomedical, Inc.2009-03-23LYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D767C0301010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pliable-polymer dental regeneration membrane, bioabsorbable, ligatedA sterile 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, well ventilated environment. Keep out of sunlight.
Storage Environment Humidity0 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
038023573
Device count
1
Lot or batch
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
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