FDA.reportPublic FDA data

GuidOss

Primary DI
08809186549585
Brand
GuidOss
Company
Nibec Co., Ltd.
Model
GDS 1-2010
Device description
GuidOss is made from pure Type I porcine collagen membrane. It is a resorbable collagen membrane for guided tissue and bone regenerations. The Type I collagen is obtained from porcine skin purified to avoid immunological reactions. The GuidOss membrane is manufactured by fibrillogenesis and glycation with sugar (ribose). The collagen fibers are self-assembled by the process of fibrillogenesis. The glycation is a natural process of cross-linking of collagen occurring in vivo. The glycated collagen fibers exhibit increased mechanical strength, thermal stability and increased resistance to pepsin digestion compared to non-glycated collagen.
Published
2016-09-23
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
K133507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133507000GUIDOSSNibec Co., Ltd.2014-11-05NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809186549585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809186549585088091865495858809186549585

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
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+827050068814webmaster@nibec.co.kr

Regulatory Flags#

DUNS number
687796909
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
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08809186542036Straumann RegenomerRSP1-S2018-08-17
08809186542043Straumann RegenomerRSP2-L2018-08-17
08809186542050Straumann RegenomerRSB1-S2018-08-17
08809186542067Straumann RegenomerRSB2-L2018-08-17
08809186549424RegenomerRSB1-S2018-08-17
08809186549431RegenomerRSB2-L2018-08-17
08809186549448RegenomerRSP1-S2018-08-17
08809186549455RegenomerRSP2-L2018-08-17
08809186540179OCS-B1-0210-0252016-09-22
08809186540186OCS-B1-0210-0502016-09-22
08809186540193OCS-B1-0210-1002016-09-22
08809186540209OCS-B1-0210-2002016-09-22
08809186540223OCS-B1-1020-0252016-09-22
08809186540230OCS-B1-1020-0502016-09-22
08809186540247OCS-B1-1020-1002016-09-22
08809186540254OCS-B1-1020-2002016-09-22
08809186540483Instradent XenoGraftI1-0210-0252016-09-23
08809186540490Instradent XenoGraftI1-0210-0502016-09-23
08809186540506Instradent XenoGraftI1-0210-1002016-09-23
08809186540513Instradent XenoGraftI1-0210-2002016-09-23

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