FDA.reportPublic FDA data

osseolink Implant

Primary DI
00816273020733
Brand
osseolink Implant
Company
OSSEOLINK USA LLC
Model
PPIN
Device description
Parallel Pin
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
00816273020733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816273020733008162730207338162730207330816273020733

GMDN Terms#

Term, Definition table
TermDefinition
Dental implantation drilling template retention pinA small, metal peg designed to provide initial stability to anchor a custom-made surgical template that is fitted over the ridge of existing teeth and/or gum of a patient during the first stage of a dental implantation procedure. It is inserted through lateral guide hole(s) in the template, and is pressed into pre-drilled hole(s) in the jawbone. It is used for implantation procedures where a tooth/teeth are missing and a template is used to provide the dentist with the correct drilling position(s) for the implant(s). 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
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136385Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
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
08809984970284S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970291S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970307S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970314S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970345S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970352S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970369S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970376S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970390S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970406S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970000S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970017S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970024S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970031S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970048S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970055S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20