NA

Primary DI
06009544011057
Brand
NA
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
IE4
Device description
Ext. Hex Cylindrical Implant, Ultra-Short, Ø3.75 x 4mm
Published
2019-01-15
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZEProsthesis, Nose, InternalGeneral, Plastic Surgery2

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
06009544011057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544011057060095440110576009544011057

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09321502015615BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502020732BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021760BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502021777BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502034579BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040075BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040082BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
09321502040099BahaCochlear Bone Anchored Solutions ABFZE2017-06-07
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00841036203979HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203986HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-14
00841036203849HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203856HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-09
00841036203689HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
00841036203771HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-08
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00841036203610HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203627HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
00841036203634HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-07
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00841036203368HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
00841036203375HTR-PMIBIOMET MICROFIXATION, INCFZE2015-12-04
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