FDA.reportPublic FDA data

CollaFlex

Primary DI
D767C0702010
Brand
CollaFlex
Company
UNICARE BIOMEDICAL INC.
Model
20mm x 30mm
Catalog number
C07-0201
Device description
Resorbable COLLAFLEX® membranes are derived from porcine pericardium through careful purification and sterilization processes to avoid antigenic reactions. The non-cross-linked membranes retain the natural microfibril structure of the pericardium, providing excellent biocompatibility and extended barrier function for guided bone regeneration applications. COLLAFLEX® membranes are easily drapable and can be fixated with sutures and bone tacks.
Published
2024-01-10
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
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200623000OssGuideSk Bioland Co., Ltd.2020-10-02NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D767C0702010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. 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 and consult instructions for use.
Special Storage Condition, Specify00Keep away from sunlight.
Special Storage Condition, Specify00Keep dry.
Storage Environment Temperature1 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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D767C0701010CollaFlex15mm x 20mmC07-01012024-01-10
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
D767C0507010Cytoflex Ti-enforced18x29mmC05-07012024-01-10

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