USSR-4603

GUDID 07290112853257

Straight abutment with shoulder GH3 Internal Hex RP

UNIQA DENTAL LTD

Dental implant suprastructure, permanent, preformed
Primary Device ID07290112853257
NIH Device Record Keydaa66da3-2656-400f-a359-7e8a1c50904f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUSSR-4603
Catalog NumberUSSR-4603
Company DUNS532098872
Company NameUNIQA DENTAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290112853257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


[07290112853257]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-09
Device Publish Date2024-09-01

Devices Manufactured by UNIQA DENTAL LTD

07290112853110 - NA2024-11-14 Castable sleeve for MUA D-type
07290112852236 - NA2024-09-27 Analog MUA D-type
07290112852410 - NA2024-09-18 Manual screw driver for abutments H8 Hex1.25
07290112852380 - NA2024-09-17 Manual screw driver for abutments H15 Hex1.25
07290112852717 - NA2024-09-17 Ratchet screw driver for abutments H10 Hex1.25
07290112852724 - NA2024-09-17 Ratchet screw driver for abutments H15 Hex1.25
07290112852731 - NA2024-09-17 Ratchet screw driver for abutments H7 Hex1.25
07290112852748 - NA2024-09-17 Ratchet screw driver for implants 2.4mm H10

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