FDA.reportPublic FDA data

Dynamix Hex (Prime)

Primary DI
07290112780652
Brand
Dynamix Hex (Prime)
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
BCSD-1638
Catalog number
BCSD-1638
Device description
Dynamix Dental Implant 3.8mm 16mm L Prime
Published
2026-07-12
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
17290112780659PackageGS110In Commercial Distribution
07290112780652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011278065917290112780659
07290112780652072901127806527290112780652

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
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

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
07290112780010Magix (Prime)BCDL-0833BCDL-08332026-07-12
07290112780522Dynamix Hex (Prime)BCSD-1050BCSD-10502026-07-12
07290112780645Dynamix Hex (Prime)BCSD-1633BCSD-16332026-07-12
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
07290114712613Titanium-basesMPN-TBH1MPN-TBH12026-07-12
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
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04