FDA.reportPublic FDA data

N/A

Primary DI
06009544019497
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
SB17TTC
Device description
Titanium Cylinder for Ø4.0 Ex Hex Passive Abutment, Non-Engaging
Published
2022-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAHSystem, Test, Tumor Marker, For Detection Of Bladder CancerUnknown3
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053478000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053478000ENDOSSEOUS DENTAL IMPLANT SYSTEMNorthern Implants, LLC2006-04-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544019497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544019497060095440194976009544019497

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
636239584
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06009544052913N/AITS6-CA52026-10-14
06009544027669N/AZGB05ML2025-04-02
06009544027676N/AZGB1ML2025-04-02
06009544027683N/AZGB2MLF2025-04-02
06009544027690N/AZGB2MLC2025-04-02
06009544027706N/AZGB1MLC2025-04-02
06009544027713N/AZGB4ML2025-04-02
06009544052876N/AICT-MW2026-10-07
06009544052883N/AICT-MW-P452026-10-07
06009544052890N/AICT-Z2026-10-07
06009544052906N/AICT-ZW2026-10-07
06009544052920N/AITS-CA52026-10-07
06009544052937N/AITS-CA5U2026-10-07
06009544053071N/AIC-Z2026-10-07
06009544053088N/AITS6-TRC52026-10-07
06009544053095N/AITS-TRC52026-10-07
06009544053101N/AITS-TRCNE-22026-10-07
06009544053118N/AITS-TRCNE-42026-10-07
06009544053125N/AICT-SP55-PM2026-10-07
06009544053132N/AICT-SP65-PM2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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088000968496738plant Implant System8dent Inc.NHA2026-10-16
088000968499498plant Implant System8dent Inc.NHA2026-10-16
088000968499638plant Implant System8dent Inc.NHA2026-10-16
088000968501438plant Implant System8dent Inc.NHA2026-10-16
088000968501508plant Implant System8dent Inc.NHA2026-10-16
088000968501678plant Implant System8dent Inc.NHA2026-10-16
088000968501818plant Implant System8dent Inc.NHA2026-10-16
088000968501988plant Implant System8dent Inc.NHA2026-10-16
088000968513248plant Implant System8dent Inc.NHA2026-10-16
088000968513318plant Implant System8dent Inc.NHA2026-10-16
088000968513488plant Implant System8dent Inc.NHA2026-10-16
088000968513558plant Implant System8dent Inc.NHA2026-10-16
088000968513628plant Implant System8dent Inc.NHA2026-10-16
088000968513798plant Implant System8dent Inc.NHA2026-10-16
088000968513868plant Implant System8dent Inc.NHA2026-10-16
088000968513938plant Implant System8dent Inc.NHA2026-10-16
088000968514308plant Implant System8dent Inc.NHA2026-10-16
088000968514478plant Implant System8dent Inc.NHA2026-10-16
088000968514548plant Implant System8dent Inc.NHA2026-10-16
088000968515088plant Implant System8dent Inc.NHA2026-10-16
088000968515918plant Implant System8dent Inc.NHA2026-10-16
088000968516458plant Implant System8dent Inc.NHA2026-10-16
088000968516528plant Implant System8dent Inc.NHA2026-10-16
088000968516698plant Implant System8dent Inc.NHA2026-10-16
088000968581328plant Implant System8dent Inc.NHA2026-10-16
088000968586518plant Implant System8dent Inc.NHA2026-10-16
088000968586688plant Implant System8dent Inc.NHA2026-10-16