FDA.reportPublic FDA data

N/A

Primary DI
06009544041306
Brand
N/A
Company
SOUTHERN IMPLANTS (PTY) LTD
Model
PKR-L-MAX7-9
Device description
Abutment Peek Temp TMAX7 9mm
Published
2024-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
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
K172160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172160000Southern Implants PEEK AbutmentsSouthern Implants (Pty), Ltd.2018-02-09NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009544041306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009544041306060095440413066009544041306

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
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
06009544047889N/ABL-EL60-112025-11-17
06009544047896N/ABL-EX30-112025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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