FDA.reportPublic FDA data

STRAUMANN EXTRAORAL IMPLANT SYSTEM

Primary DI
07630031722409
Brand
STRAUMANN EXTRAORAL IMPLANT SYSTEM
Company
Institut Straumann AG
Model
EO
Catalog number
048.044
Device description
EO Healing cap, D 3.5mm, L 3.8mm, Ti
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990458000STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USA1999-04-16KCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031722409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031722409076300317224097630031722409

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.8Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03
07630031778208NAsurgically Invasive Instruments066.50752026-06-03
07630031778215NAsurgically Invasive Instruments066.50762026-06-03
07630031778222NAsurgically Invasive Instruments066.50772026-06-03
07630031778239NAsurgically Invasive Instruments066.50782026-06-03
07630031778260NAsurgically Invasive Instruments066.50812026-06-03
07630031778277NAsurgically Invasive Instruments066.50822026-06-03
07630031778284NAsurgically Invasive Instruments066.50832026-06-03
07630031778291NAsurgically Invasive Instruments066.50842026-06-03
07630031778307NAsurgically Invasive Instruments066.50852026-06-03
07630031778338NAsurgically Invasive Instruments066.50882026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070202999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08800070203200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-02
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28