FDA.reportPublic FDA data

creos™ syntoprotect

Primary DI
07332747193497
Brand
creos™ syntoprotect
Company
Nobel Biocare AB
Model
N1615TI-A13-1
Catalog number
N1615TI-A13-1
Device description
creos syntoprotect Ti-150 No13
Published
2022-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747193497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747193497073327471934977332747193497

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
Height150Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Lower limit of temperature * 15°C. Upper limit of temperature * 30°C
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags#

DUNS number
353939929
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747214918Nobel Biocare®3019313019312026-04-09
07332747214925Nobel Biocare®3019323019322026-04-09
07332747214932Nobel Biocare®3019333019332026-04-09
07332747214949Nobel Biocare®3019343019342026-04-09
07332747221510Nobel Biocare®3022543022542026-04-09
07332747221527Nobel Biocare®3022553022552026-04-09
07332747221534Nobel Biocare®3022563022562026-04-09
07332747223385Nobel Biocare®3022653022652026-04-09
07332747223392Nobel Biocare®3022643022642026-04-09
07332747223408Nobel Biocare®3022663022662026-04-09
07332747224436Nobel Biocare®3024853024852026-04-09
07332747224443Nobel Biocare®3024863024862026-04-09
07332747224450Nobel Biocare®3024883024882026-04-09
07332747224467Nobel Biocare®3024873024872026-04-09
07332747224474Nobel Biocare®3024893024892026-04-09
07332747224481Nobel Biocare®3024903024902026-04-09
07332747236620DTX Studio™ Clinic4.83008512026-03-27
07332747236637DTX Studio™ Clinic4.83008512026-03-27
07332747219616DTX Studio™ Clinic4.43008512025-01-26
07332747219623DTX Studio™ Clinic4.43008512025-01-26

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