FDA.reportPublic FDA data

Oradapt

Primary DI
08800048502502
Brand
Oradapt
Company
HYUNDAI BIOLAND Co., Ltd.
Model
OA3040
Device description
Absorbable collagen membrane
Published
2023-06-15
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

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
08800048502502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800048502502088000485025028800048502502

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
Length40Millimeter
Width30Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688235061
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800048502892TBS DentalTBSRGN052024-06-05
08800048502908TBS DentalTBSRGN062024-06-05
08800048502915TBS DentalTBSRGN072024-06-05
08800048502519OradaptOA20302023-06-15
08800048502526OradaptOA15202023-06-15
08800048502342T-GenTG-12023-04-18
08800048502359T-GenTG-22023-04-18
08800048502366T-GenTG-32023-04-18
08800048502373T-GenTG-42023-04-18
08800048502380T-GenTG-52023-04-18
08800048502236OsseoSealOS15202022-03-08
08800048502243OsseoSealOS20302022-03-08
08800048502250OsseoSealOS30402022-03-08
08800048502168XP-SealXP-12021-09-17
08800048502175XP-SealXP-22021-09-17
08800048502182XP-SealXP-32021-09-17
08800048502045OssGuideTG-12020-11-27
08800048502052OssGuideTG-22020-11-27
08800048502069OssGuideTG-32020-11-27
08800048502076OssGuideTG-42020-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632304DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632311DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632328DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632359DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632366DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632373DynaMatrix PlusCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632878DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632885DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632892DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632908DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632915DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632922DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
07610221017645Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017652Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
07610221017669Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
09421907331614Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331621Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331638Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331652Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331706Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331713Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331720Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331744Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331799Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331805Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331812Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331836Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
06974944921339NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921346NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921353NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16