FDA.report

creos™ syntoprotect

Primary DI
07332747193299
Brand
creos™ syntoprotect
Company
Nobel Biocare AB
Model
N1625TI-A07-1
Catalog number
N1625TI-A07-1
Device description
creos syntoprotect Ti-250 No7
Published
2022-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NPKBarrier, synthetic, intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747193299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747193299073327471932997332747193299

GMDN Terms

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

TypeValueUnit
Height250Micrometer

Storage And Handling

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

Contacts

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

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07332747225587NA3025693025692026-03-02
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07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

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