FDA.reportPublic FDA data

Spline®

Primary DI
00889024012608
Brand
Spline®
Company
ZimVie US Corp LLC
Model
1806
Published
2015-10-16
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
K001786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001786000TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOGSulzer Calcitek, Inc.2000-06-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024012608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024012608008890240126088890240126080889024012608

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7019zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
119287313
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844868052463T3® ProDEPTHGTRAYN/A2026-05-28
00844868052470T3® PROEXHEXTOOLTRAY2026-05-28
00844868052487T3® PROOPENWRENCHTRAYN/A2026-05-28
00844868052494T3® PROT3PDRILLTRAYN/A2026-05-28
00844868052500T3® PROT3PLIDBASE2026-05-28
00844868052517T3® PROT3PTAPTRAY342026-05-28
00844868052524T3® PROT3PTAPTRAY56N/A2026-05-28
00844868052531T3® PROT3PTOOLTRAYN/A2026-05-28
00844868052548T3® ShortT3SHORTTRAYN/A2026-05-28
00844868052814Terrats Competitive Connection AbutmentsMALDAGU2026-05-18
00844868052821Terrats Competitive Connection AbutmentsNALDAG352026-05-18
00844868052838Terrats Competitive Connection AbutmentsNBLDAG512026-05-18
00844868052845Terrats Competitive Connection AbutmentsTXLDAT32026-05-18
00844868052852Terrats Competitive Connection AbutmentsNRLDAG432026-05-18
00844868052890Terrats Competitive Connection AbutmentsMSLDAG372026-05-18
00844868052906Terrats Competitive Connection AbutmentsMSLDAT452026-05-18
00844868052913Terrats Competitive Connection AbutmentsNALDAG432026-05-18
00844868052937Terrats Competitive Connection AbutmentsNRLDAG502026-05-18
00844868052951Terrats Competitive Connection AbutmentsNBLDAG352026-05-18
00844868052968Terrats Competitive Connection AbutmentsSTLDAT652026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08809822767892AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767908AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767922AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767946AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12
08809822767953AnyOne Internal FixtureMegagen Implant Co. LtdDZE2023-06-12