FDA.reportPublic FDA data

Cylindrical Dental Implant CDI

Primary DI
07290119313037
Brand
Cylindrical Dental Implant CDI
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
4.2mm diameter x 13mm length
Catalog number
BIO-G4213
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K250872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250872000Bioline Dental Implant SystemBioline Dental Implant Systems, Ltd.2025-06-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290119313037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290119313037072901193130377290119313037

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Regulatory Flags#

DUNS number
532209134
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290119312917Cylindrical Dental Implant CDI3.3mm diameter x 10mm lengthBIO-G33102026-05-18
07290119312924Cylindrical Dental Implant CDI3.3mm diameter x 11.5mm lengthBIO-G33112026-05-18
07290119312931Cylindrical Dental Implant CDI3.3mm diameter x 13mm lengthBIO-G33132026-05-18
07290119312948Cylindrical Dental Implant CDI3.3mm diameter x 16mm lengthBIO-G33162026-05-18
07290119312955Cylindrical Dental Implant CDI3.75mm diameter x 8mm lengthBIO-G37082026-05-18
07290119312962Cylindrical Dental Implant CDI3.75mm diameter x 10mm lengthBIO-G37102026-05-18
07290119312979Cylindrical Dental Implant CDI3.75mm diameter x 11.5mm lengthBIO-G37112026-05-18
07290119312986Cylindrical Dental Implant CDI3.75mm diameter x 13mm lengthBIO-G37132026-05-18
07290119312993Cylindrical Dental Implant CDI3.75mm diameter x 16mm lengthBIO-G37162026-05-18
07290119313006Cylindrical Dental Implant CDI4.2mm diameter x 8mm lengthBIO-G42082026-05-18
07290119313013Cylindrical Dental Implant CDI4.2mm diameter x 10mm lengthBIO-G42102026-05-18
07290119313020Cylindrical Dental Implant CDI4.2mm diameter x 11.5mm lengthBIO-G42112026-05-18
07290119313044Cylindrical Dental Implant CDI4.2mm diameter x 16mm lengthBIO-G42162026-05-18
07290119313051Cylindrical Dental Implant CDI5mm diameter x 8mm lengthBIO-G50082026-05-18
07290119313068Cylindrical Dental Implant CDI5mm diameter x 10mm lengthBIO-G50102026-05-18
07290119313075Cylindrical Dental Implant CDI5mm diameter x 11.5mm lengthBIO-G50112026-05-18
07290119313082Cylindrical Dental Implant CDI5mm diameter x 13mm lengthBIO-G50132026-05-18
07290119313099Cylindrical Dental Implant CDI5mm diameter x 16mm lengthBIO-G50162026-05-18
07290119313105Cylindrical Dental Implant CDI6mm diameter x 8mm lengthBIO-G60082026-05-18
07290119313112Cylindrical Dental Implant CDI6mm diameter x 10mm lengthBIO-G60102026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26