FDA.reportPublic FDA data

N/A

Primary DI
06009544007593
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
GC-NX-70
Device description
Gold Abutment, Non-Engaging, for Max9 Ex Hex
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052490000ENDOSSEOUS DENTAL IMPLANT SYSTEMNorthern Implants, LLC2005-12-08DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544007593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544007593060095440075936009544007593

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
06009544039808N/APPC-3M2026-09-18
06009544039815N/APPC-3MS2026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020806819SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806826SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806833SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806871SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806888SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020806895SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807113SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807120SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807137SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807144SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807274SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807281SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807298SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020807304SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840684SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840691SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840707SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840714SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840769SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020840776SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841124SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841131SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841148SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841155SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841162SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
08800020841179SNUCONE TISSUE LEVEL IMPLANT SYSTEMSNUCONE Co.,LTD.NHA2026-09-18
00842448118561TITAN IMPLANTS INC.TITAN IMPLANT INCNHA2026-09-06
00810125998713ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998720ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04
00810125998737ET Scan Healing AbutmentHIOSSEN, INC.NHA2026-09-04