FDA.reportPublic FDA data

Solidex

Primary DI
D124SM33S0
Brand
Solidex
Company
Creo Dent Hudson Valley, Inc.
Model
SM33S
Device description
Screw Compatible with Sweden & Martina Premium 3.3mm Implant Platform
Published
2025-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
K170100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170100000CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.2017-07-18NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D124SM33S0PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D124EK0SolidexEK2025-02-12
D124EKBL0SolidexEKBL2025-02-12
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
D124PMMNE0InosysPMMNE2024-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516877992SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878005SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878012SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878029SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878036SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878043SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878050SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878067SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878074SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878081SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878098SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878104SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878111SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878128SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878135SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878142SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878159SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878166SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878173SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878180SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04099797001099CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001105CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001112CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001129CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001136CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001143CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001150CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001167CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001174CONELOG® Healing capALTATEC GmbHNHA2026-08-17
04099797001181CONELOG® Healing capALTATEC GmbHNHA2026-08-17