FDA.reportPublic FDA data

osseolink Implant

Primary DI
00816273020689
Brand
osseolink Implant
Company
OSSEOLINK USA LLC
Model
ITWISO
Device description
Variable Torque Wrench
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
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
K091878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091878000OSSEOLINK DENTAL IMPLANT SYSTEMGlobal Implant Solutions, LLC2009-10-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816273020689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816273020689008162730206898162730206890816273020689

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial register (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)677-3688info@osseolink.com

Regulatory Flags#

DUNS number
080083007
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816273020672osseolink ImplantDADAP2017-05-18
00816273020146osseolink Implant019112017-05-18
00816273020153osseolink Implant019122017-05-18
00816273020160osseolink Implant019132017-05-18
00816273020177osseolink Implant019142017-05-18
00816273020184osseolink Implant019152017-05-18
00816273020191osseolink Implant8519-22017-05-18
00816273020207osseolink Implant8540-22017-05-18
00816273020214osseolink Implant83932017-05-18
00816273020221osseolink ImplantUCLAGE2017-05-18
00816273020238osseolink ImplantUCLAPNE2017-05-18
00816273020245osseolink ImplantTI402017-05-18
00816273020252osseolink ImplantTI502017-05-18
00816273020269osseolink ImplantTI40N2017-05-18
00816273020276osseolink ImplantTI40N02017-05-18
00816273020283osseolink ImplantTI40N42017-05-18
00816273020290osseolink ImplantTI50N2017-05-18
00816273020306osseolink ImplantTI50N02017-05-18
00816273020313osseolink ImplantTI50N42017-05-18
00816273020320osseolink ImplantTI40NC2017-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
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