FDA.reportPublic FDA data

Titanium-bases

Primary DI
07290114712613
Brand
Titanium-bases
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
MPN-TBH1
Catalog number
MPN-TBH1
Device description
Titanium base H1 - Narrow Platform lock
Published
2026-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K163385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163385000Cortex Dental Implant SystemCortex Dental Implants Industries , Ltd.2017-08-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114712613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114712613072901147126137290114712613

GMDN Terms#

Term, Definition table
TermDefinition
Bar dental precision attachmentA small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532376956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07290112780010Magix (Prime)BCDL-0833BCDL-08332026-07-12
07290112780522Dynamix Hex (Prime)BCSD-1050BCSD-10502026-07-12
07290112780645Dynamix Hex (Prime)BCSD-1633BCSD-16332026-07-12
07290112780652Dynamix Hex (Prime)BCSD-1638BCSD-16382026-07-12
07290112781215Saturn (Prime)BST-1038BST-10382026-07-12
07290112781222Saturn (Prime)BST-1042BST-10422026-07-12
07290112781246Saturn (Prime)BST-1142BST-11422026-07-12
07290112781260Saturn (Prime)BST-1342BST-13422026-07-12
07290112781284Saturn (Prime)BST-1642BST-16422026-07-12
07290112781710Dynamix Hex (Premium)PCSD-1038PCSD-10382026-07-12
07290112781727Dynamix Hex (Premium)PCSD-1042PCSD-10422026-07-12
07290114710411Healing CapCO-7103CO-71032026-07-12
07290114710565AbutmentsCO-8015CO-80152026-07-12
07290114712156Abutments-AnalogMPN-8040DMPN-8040D2026-07-12
07290116660677Surgical DrillsCK-GS11CK-GS112026-07-12
07290116660882Surgical ToolsCT-0254CT-02542026-07-12
07290116660899Surgical ToolsCT-0260CT-02602026-07-12
07290116660981Surgical ToolsCT-0801CT-08012026-07-12
07290116661216Surgical ToolsCT-S215CT-S2152026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22