FDA.reportPublic FDA data

Solidex

Primary DI
D124ST48B140
Brand
Solidex
Company
Creo Dent Hudson Valley, Inc.
Model
ST48B14
Device description
14mm Blank Compatible with Straumann Bone Level RC Implant Platform
Published
2023-07-19
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
D124ST48B140PrimaryHIBCC0

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
D124EK0SolidexEK2025-02-12
D124EKBL0SolidexEKBL2025-02-12
D124SM33S0SolidexSM33S2025-02-12
D124SM33S100SolidexSM33S102025-02-12
D124SM33S50SolidexSM33S52025-02-12
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
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
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
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