FDA.reportPublic FDA data

Dynamix Hex (Prime)

Primary DI
07290112780461
Brand
Dynamix Hex (Prime)
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
BCSD-0842
Catalog number
BCSD-0842
Device description
Dynamix Dental Implant 4.2mm 8mm L Prime
Published
2026-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090709000CORTEX DENTAL IMPLANT SYSTEMCortex Dental Implants Industries , Ltd.2009-07-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290112780468PackageGS110In Commercial Distribution
07290112780461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011278046817290112780468
07290112780461072901127804617290112780461

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00keep Dry

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290112780027Magix (Prime)BCDL-0838BCDL-08382026-09-08
07290112780454Dynamix Hex (Prime)BCSD-0838BCSD-08382026-09-08
07290112780478Dynamix Hex (Prime)BCSD-0850BCSD-08502026-09-08
07290112780492Dynamix Hex (Prime)BCSD-1033BCSD-10332026-09-08
07290112780546Dynamix Hex (Prime)BCSD-1133BCSD-11332026-09-08
07290112780553Dynamix Hex (Prime)BCSD-1138BCSD-11382026-09-08
07290112780577Dynamix Hex (Prime)BCSD-1150BCSD-11502026-09-08
07290112780591Dynamix Hex (Prime)BCSD-1333BCSD-13332026-09-08
07290112780607Dynamix Hex (Prime)BCSD-1338BCSD-13382026-09-08
07290112780669Dynamix Hex (Prime)BCSD-1642BCSD-16422026-09-08
07290112781109Dynamix Conical (Prime)BMCD-1330BMCD-13302026-09-08
07290112781154Dynamix Conical (Prime)BMCD-1630BMCD-16302026-09-08
07290112781666Dynamix Hex (Premium)PCSD-0838PCSD-08382026-09-08
07290112781673Dynamix Hex (Premium)PCSD-0842PCSD-08422026-09-08
07290112781703Dynamix Hex (Premium)PCSD-1033PCSD-10332026-09-08
07290112781758Dynamix Hex (Premium)PCSD-1133PCSD-11332026-09-08
07290112781765Dynamix Hex (Premium)PCSD-1138PCSD-11382026-09-08
07290112780010Magix (Prime)BCDL-0833BCDL-08332026-07-12
07290112780522Dynamix Hex (Prime)BCSD-1050BCSD-10502026-07-12
07290112780652Dynamix Hex (Prime)BCSD-1638BCSD-16382026-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532000430Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000447Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000874Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000942Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532000959Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002731Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532002748Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037115Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532037122Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049613Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049620Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049637Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049644Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049651Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532049668Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532062841Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-11-04
07392532036965Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036972Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532036989Astra Tech Implant System®Dentsply Implants Manufacturing GmbHDZE2025-10-17
07392532049576ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532049583ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066047ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31
07392532066054ASTRA TECH Implant System®Dentsply Implants Manufacturing GmbHDZE2015-10-31