GUDID 06009544049890

Abutment TOP PKC Ø3.5/4 DC Central

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID06009544049890
NIH Device Record Keyf8c1091a-5515-4f7b-bfdb-ab4f68e2ec63
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPKC-TOP1-DC4
Company DUNS636239584
Company NameSOUTHERN IMPLANTS (PTY) LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106009544049890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-14
Device Publish Date2025-01-06

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

06009544050568 - N/A2025-07-24 V2-GC-90772
06009544050643 - N/A2025-07-24 Instrument Tray for Zygomatic, Large
06009544000105 - NA2025-07-17 Abutment Healing Int Hex PM 6.5x6
06009544050438 - N/A2025-07-17 Abutment Healing SP1 ø3.8x2.5mm
06009544050445 - N/A2025-07-17 Abutment Healing SP1 ø3.8x3.5mm
06009544050452 - N/A2025-07-17 Abutment Healing SP1 ø3.8x4.5mm
06009544050469 - N/A2025-07-17 Abutment Healing SP1 ø3.8x5.5mm
06009544050476 - N/A2025-07-17 Abutment Healing SP1 ø3.8x6.5mm

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