FDA.reportPublic FDA data

Dynamix Conical (Prime)

Primary DI
07290112781130
Brand
Dynamix Conical (Prime)
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
BMCD-1342
Catalog number
BMCD-1342
Device description
Conic Dynamix Implant 4.2mm 13mm L Prime
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
MHAHyperthermia By Ultrasound For Brain Tumor Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
MHAHyperthermia By Ultrasound For Brain Tumor Therapy

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
17290112781137PackageGS110In Commercial Distribution
07290112781130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011278113717290112781137
07290112781130072901127811307290112781130

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
07290114710756prosthetics - TransferCO-8070CO-80702026-10-14
07290114710787prosthetics - Long Term abutmentsCO-8075CO-80752026-10-14
07290114710800prosthetics - Long Term abutmentsCO-8080CCO-8080C2026-10-14
07290114710831prosthetics - Long Term abutmentsCO-8100CO-81002026-10-14
07290114710848prosthetics - Long Term abutmentsCO-8100CCO-8100C2026-10-14
07290114711654prosthetics - Long Term abutmentsCO-TBCRCCO-TBCRC2026-10-14
07290114711661prosthetics - Long Term abutmentsCO-TBCRCRCO-TBCRCR2026-10-14
07290114712026prosthetics - Long Term abutmentsMPN-5418MPN-54182026-10-14
07290114712170prosthetics - Long Term abutmentsMPN-8080MPN-80802026-10-14
07290114712651prosthetics - Long Term abutmentsMPN-TBR2MPN-TBR22026-10-14
07290114712668prosthetics - Long Term abutmentsMPN-TBR3MPN-TBR32026-10-14
07290114713054prosthetics -TransferMPR-8080MPR-80802026-10-14
07290114713429prosthetics - Long Term abutmentsMPR-TBCRCRMPR-TBCRCR2026-10-14
07290114713948prosthetics - Long Term abutmentsMPW-9215MPW-92152026-10-14
07290114714570prosthetics -Cover screwMPW-S006MPW-S0062026-10-14
07290116660295Surgical DrillsCD-GS1037CD-GS10372026-10-14
07290116662046Surgical DrillsCD-GS1041CD-GS10412026-10-14
07290114711548prosthetics - Long Term abutmentsCO-S030CO-S0302026-10-13
07290114711630prosthetics - Long Term abutmentsCO-SBZZCO-SBZZ2026-10-13
07290114712491prosthetics - Long Term abutmentsMPN-S030MPN-S0302026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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