FDA.reportPublic FDA data

Bonafix

Primary DI
00850074346197
Brand
Bonafix
Company
Zentek Medical LLC
Model
BTIM5016N
Device description
Bonafix Two Implant 5.00 x 16mm Finished
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K213677000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213677000Bonafix 2 PlusZentek Medical, LLC2022-12-20DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850074346197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850074346197008500743461978500743461970850074346197

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7329792502info@bonafixsdi.com

Regulatory Flags#

DUNS number
086804993
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
00850074346005BonafixBTIM3508N2025-06-03
00850074346012BonafixBTIM3510N2025-06-03
00850074346029BonafixBTIM3511N2025-06-03
00850074346036BonafixBTIM3513N2025-06-03
00850074346043BonafixBTIM3516N2025-06-03
00850074346050BonafixBTIM3708N2025-06-03
00850074346067BonafixBTIM3710N2025-06-03
00850074346074BonafixBTIM3711N2025-06-03
00850074346081BonafixBTIM3713N2025-06-03
00850074346098BonafixBTIM3716N2025-06-03
00850074346104BonafixBTIM4208N2025-06-03
00850074346111BonafixBTIM4210N2025-06-03
00850074346128BonafixBTIM4211N2025-06-03
00850074346135BonafixBTIM4213N2025-06-03
00850074346142BonafixBTIM4216N2025-06-03
00850074346159BonafixBTIM5008N2025-06-03
00850074346166BonafixBTIM5071N2025-06-03
00850074346173BonafixBTIM5010N2025-06-03
00850074346180BonafixBTIM5013N2025-06-03
00850074346203BonafixBTIM6008N2025-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28