FDA.reportPublic FDA data

Compact Axis Surgical Kit

Primary DI
10810190017842
Brand
Compact Axis Surgical Kit
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
A
Catalog number
KT1-0006
Published
2016-01-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K143326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143326000T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.2015-05-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810190017842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001784210810190017842

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmAR-6593-09-11159110ar2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmAR-6593-09-13159130ar2026-07-16
10810128462867VersiTILT 2.4 x 8.5mm Implant System3910-700-010505100st2026-07-16
10810128462874VersiTILT 2.4 x 8.5mm Button and Inserter3910-700-011505101st2026-07-16
10810128462881VersiTILT Drill Pin, 3.1mm3910-700-012505102st2026-07-16
10810128462898VersiTILT Button, 2.4x8.5mm3910-700-013505103st2026-07-16
10810128462904VersiTILT 2.4x12mm Implant System, Long3910-700-020505200st2026-07-16
10810128462911VersiTILT 2.4x12mm Button and Inserter, Long3910-700-021505201st2026-07-16
10810128462928VersiTILT Button, 2.4x12mm3910-700-023505203st2026-07-16
10810128462935VersiTILT 3.1x10.9mm Implant System, XL3910-700-030505300st2026-07-16
10810128462942VersiTILT 3.1x10.9mm Button and Inserter, XL3910-700-031505301st2026-07-16
10810128462959VersiTILT Drill Pin, 3.6mm3910-700-032505302st2026-07-16
10810128462966VersiTILT Button, 3.1x10.9mm3910-700-033505303st2026-07-16
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®AR-4580176200ar2023-09-27

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