FDA.report

Nobel Biocare N1™

Primary DI
07332747196597
Brand
Nobel Biocare N1™
Company
Nobel Biocare AB
Model
301511
Catalog number
301511
Device description
Titanium Abutment Blank Nobel Biocare N1™ TCC NP Ø10 mm
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PNPDental abutment design software for dental laboratory

Product Code Classifications

CodeDeviceSpecialtyClass
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747196597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747196597073327471965977332747196597

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes

TypeValueUnit
Outer Diameter10Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07332747225549NobelActive®3025653025652026-03-02
07332747225556NobelActive®3025663025662026-03-02
07332747225563NA3025673025672026-03-02
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07332747221961NobelActive® S TiUltra™3022753022752026-02-26
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07332747221992NobelActive® S TiUltra™3022783022782026-02-26
07332747222005NobelActive® S TiUltra™3022793022792026-02-26
07332747222012NobelActive® S TiUltra™3022803022802026-02-26
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07332747222036NobelActive® S TiUltra™3022823022822026-02-26
07332747222043NobelActive® S TiUltra™3022833022832026-02-26
07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

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00847236027926BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
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