FDA.reportPublic FDA data

Solidex

Primary DI
D1243I606NE0
Brand
Solidex
Company
Creo Dent Hudson Valley, Inc.
Model
3I606NE
Device description
6mm Nonengaging Ti-Link Compatible with Biomet 3i Certain Internal 6.0mm Implant Platform
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202909000CreoDent Solidex Customized AbutmentCreodent Prosthetics, Ltd.2021-04-02NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1243I606NE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, custom-madeA custom-made device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; an abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure and is manufactured for a specific patient.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
071221112
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D124MGAR0SolidexMGAR2026-05-11
D124MGAR60SolidexMGAR62026-05-11
D124MGARNE0SolidexMGARNE2026-05-11
D124ST48NE0SolidexST48NE2023-07-19
D124ST330SolidexST332023-06-21
D124ST3360SolidexST3362023-06-21
D124ST33NE0SolidexST33NE2023-06-21
D124ST480SolidexST482023-06-21
D124ST4860SolidexST4862023-06-21
D124EK0SolidexEK2025-02-12
D124EKBL0SolidexEKBL2025-02-12
D124SM33S0SolidexSM33S2025-02-12
D124SM33S100SolidexSM33S102025-02-12
D124SM33S50SolidexSM33S52025-02-12
D124CREOKORREKT0CreodentCREOKORREKT2024-08-20
D124PMRBL0InosysPMRBL2024-02-16
D124PMM0InosysPMM2024-02-09
D124PMM60InosysPMM62024-02-09
D124PMMBL0InosysPMMBL2024-02-09
D124PMMBL140InosysPMMBL142024-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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