FDA.reportPublic FDA data

N/A

Primary DI
06009544000648
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
ABZ3
Device description
Standard Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.5 x 3mm
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZEProsthesis, Nose, Internal
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161548000Osseointegrated FixturesSouthern Implants (Pty), Ltd.2016-12-01FZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544000648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544000648060095440006486009544000648

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

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
06009544030287N/AIC-K4262026-10-01
06009544052401N/ACMC12026-10-01
06009544052418N/ACMCW12026-10-01
06009544052425N/ACNB5-152026-10-01
06009544052432N/ACP2026-10-01
06009544052517N/ACMC22026-10-01
06009544052524N/ACMC2L2026-10-01
06009544052531N/ACMCW22026-10-01
06009544052548N/ACMC-ZG-22026-10-01
06009544052555N/ACSD42026-10-01
06009544052630N/AIC-DC32026-10-01
06009544052647N/AIC-DC3-W2026-10-01
06009544052654N/AIC-DC42026-10-01
06009544052661N/AIC-DC4-W2026-10-01
06009544052678N/AIC-DC52026-10-01
06009544052685N/AIC-DC5-W2026-10-01
06009544052692N/AIC-DCR52026-10-01
06009544052708N/AIC-K4062026-10-01
06009544052715N/AIC-K4162026-10-01
06009544052722N/AIC-K5062026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-01
06009544052036N/ASOUTHERN IMPLANTS (PTY) LTDNHA2026-09-30
00840481138492LOCATOR, compatible with Nobel BiocareZest Anchors, LLCNHA2026-09-29
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-09-29