FDA.reportPublic FDA data

N/A

Primary DI
06009544046790
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
SIB-NL-35-43C1.5
Device description
SI-Base Abutment, Non- Engaging, for Ø3.5 Tri-Nex, Ø4.3 x 1.5mm Collar
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230873000Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.2023-08-01NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544046790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544046790060095440467906009544046790

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder immobilizer/orthosis, single-useA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a single-use device.

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
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
06009544053149N/AICT-SP452026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
08809984989040S-PlantIDIS CO.,LTDNHA2026-10-07
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
08809984970895S-PlantIDIS CO.,LTDNHA2026-10-07
08809984981518S-PlantI Dis Co., Ltd.NHA2026-10-07
D7702764233TRANSGINGIVAL HEALING CAP H3MMSWEDEN & MARTINA SPANHA2026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMSWEDEN & MARTINA SPANHA2026-10-07
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014740Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014757Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014764Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014771Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06