FDA.reportPublic FDA data

N/A

Primary DI
06009544019824
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
SC4
Device description
Coverscrew for Ø3.75 IE
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
DZEImplant, Endosseous, Root-Form
FZEProsthesis, Nose, Internal
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2
NDPAccessories, Implant, Dental, EndosseousDental1

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
06009544019824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544019824060095440198246009544019824

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. 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
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
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052432N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052517N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052524N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052531N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052548N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052555N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052630N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052647N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052654N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052661N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052678N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052685N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052692N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052708N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052715N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052722N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052739N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052746N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052753N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052760N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052777N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053224N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053255N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053262N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053279N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544053286N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01