FDA.reportPublic FDA data

creos™ syntoprotect

Primary DI
17332747181866
Brand
creos™ syntoprotect
Company
Nobel Biocare AB
Model
N161224-1
Catalog number
N161224-1
Device description
creos™ syntoprotect PTFE membrane 200 12 x 24 mm. Also available in a pack of 10 with catalog number N161224-10, as creos™ syntoprotect PTFE membrane 200 12 x 24 mm 10x.
Published
2021-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone grafting material, synthetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17332747181866PackageGS110In Commercial Distribution
07332747181869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1733274718186617332747181866
07332747181869073327471818697332747181869

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
Height200Micrometer

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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