FDA.report

Nobel Biocare®

Primary DI
07332747190397
Brand
Nobel Biocare®
Company
Nobel Biocare AB
Model
36650
Catalog number
36650
Device description
Cover Screw Conical Connection RP
Published
2024-05-28
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
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747190397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747190397073327471903977332747190397

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Storage And Handling

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

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
true
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 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 DIBrandCompanyProduct codePublished
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100118DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100125DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100132DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100149DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100156DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100163DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100170DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100187DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100194DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100200DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100217DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100224DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100231DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100248DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100255DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100262DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20