FDA.reportPublic FDA data

osseolink Implant

Primary DI
00816273020726
Brand
osseolink Implant
Company
OSSEOLINK USA LLC
Model
IPG
Device description
Implant Placement Guide
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
00816273020726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816273020726008162730207268162730207260816273020726

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. 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
00816273020689osseolink ImplantITWISO2017-05-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841307136392Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
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