FDA.reportPublic FDA data

Nobel Biocare N1™

Primary DI
07332747214116
Brand
Nobel Biocare N1™
Company
Nobel Biocare AB
Model
300948
Catalog number
300948
Device description
Universal Abutment Nobel Biocare N1™ TCC RP 1.5mm
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNPDental abutment design software for dental laboratory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNPDental Abutment Design Software For Dental LaboratoryDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332747214116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332747214116073327472141167332747214116

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Height1.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332747225549NobelActive®3025653025652026-03-02
07332747225556NobelActive®3025663025662026-03-02
07332747225563NA3025673025672026-03-02
07332747225570NA3025683025682026-03-02
07332747225587NA3025693025692026-03-02
07332747225594NA3025703025702026-03-02
07332747225839NobelActive®3025833025832026-03-02
07332747221947NobelActive® S TiUltra™3022733022732026-02-26
07332747221954NobelActive® S TiUltra™3022743022742026-02-26
07332747221961NobelActive® S TiUltra™3022753022752026-02-26
07332747221978NobelActive® S TiUltra™3022763022762026-02-26
07332747221985NobelActive® S TiUltra™3022773022772026-02-26
07332747221992NobelActive® S TiUltra™3022783022782026-02-26
07332747222005NobelActive® S TiUltra™3022793022792026-02-26
07332747222012NobelActive® S TiUltra™3022803022802026-02-26
07332747222029NobelActive® S TiUltra™3022813022812026-02-26
07332747222036NobelActive® S TiUltra™3022823022822026-02-26
07332747222043NobelActive® S TiUltra™3022833022832026-02-26
07332747222050NobelActive® S TiUltra™3022843022842026-02-26
07332747222067NobelActive® S TiUltra™3022853022852026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00847236027797BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027803BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027810BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027827BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027834BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027841BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027896BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027902BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027919BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
00847236027926BioHorizonsBIOHORIZONS IMPLANT SYSTEMS, INCPNP2026-02-26
04260521363633Ceramill M-Plantexocad GmbHPNP2026-02-02
08435566638831IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638848IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638855IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638862IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638893IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638923IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638930IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638978IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638985IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566638992IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639005IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639012IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639029IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639036IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639111IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639128IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639166IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639173IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30
08435566639180IPDIMPLANT PROTESIS DENTAL 2004 SLPNP2026-01-30