UCI-3311

GUDID 07290112855527

Implant P&P D3.3 L11.5 Conical 11deg RP

UNIQA DENTAL LTD

Screw endosteal dental implant, two-piece
Primary Device ID07290112855527
NIH Device Record Keyf915b31e-ac57-4a29-ae13-04a4a2c272be
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUCI-3311
Catalog NumberUCI-3311
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 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
GS107290112855527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-30
Device Publish Date2024-08-22

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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