FDA.reportPublic FDA data

NA

Primary DI
06009544037705
Brand
NA
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
TS-Z-MC-16
Device description
Hexed Titanium Screw for Ø3.3 Provata®, Angled Abutment
Published
2023-06-13
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
K222457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222457000Provata Implant SystemSouthern Implants (Pty), Ltd.2023-03-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544037705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544037705060095440377056009544037705

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
636239584
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
06009544033622N/ASFT-EX-302026-02-26
06009544010425NAIC-DC32018-11-27
06009544026266NATSIT2-ASC2025-12-19
06009544050919N/AASC-DC52025-12-19
06009544050926N/AASC-ITS2025-12-19
06009544050957N/AI-GSF-5142-L42025-12-18
06009544050964N/AI-GSF-5142-L62025-12-18
06009544050971N/AI-GSF-6252-L42025-12-18
06009544050988N/AI-GSF-6252-L62025-12-18
06009544050995N/AI-GSF-6252-L4-P52025-12-18
06009544051008N/AI-GSCF-6252-L62025-12-18
06009544047810N/ABL-3M-112025-11-17
06009544047827N/ABL-DC3-112025-11-17
06009544047834N/ABL-DC4-112025-11-17
06009544047841N/ABL-DC5-112025-11-17
06009544047858N/ABL-EL35-112025-11-17
06009544047865N/ABL-EL43-112025-11-17
06009544047872N/ABL-EL50-112025-11-17
06009544047889N/ABL-EL60-112025-11-17
06009544047896N/ABL-EX30-112025-11-17

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