UCLA, Ti, NARROW CONICAL, NON-HEX

GUDID D824UCLATONC0

SURGIKOR, LLC

Basket endosteal dental implant, two-piece
Primary Device IDD824UCLATONC0
NIH Device Record Keyaa1e90c0-3171-4389-9e06-58ae16a03f2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCLA, Ti, NARROW CONICAL, NON-HEX
Version Model NumberUCLATONC
Company DUNS080321629
Company NameSURGIKOR, LLC
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 Numbertrue
Manufacturing Datefalse
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
HIBCCD824UCLATONC0 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-21
Device Publish Date2019-08-13

Devices Manufactured by SURGIKOR, LLC

D824FRC43100 - Fixation One2025-12-23 Ø4.3mm x L10.0mm, Conical Connection, Regular Platform
D824FRC43110 - Fixation One2025-12-23 Ø4.3mm x L11.5mm, Conical Connection, Regular Platform
D824FRC43130 - Fixation One2025-12-23 Ø4.3mm x L13.0mm, Conical Connection, Regular Platform
D824FRC43150 - Fixation One2025-12-23 Ø4.3mm x L15.0mm, Conical Connection, Regular Platform
D824FRC43180 - Fixation One2025-12-23 Ø4.3mm x L18.0mm, Conical Connection, Regular Platform
D824FRC50080 - Fixation One2025-12-23 Ø5.0mm x L8.5mm, Conical Connection, Regular Platform
D824FRC50100 - Fixation One2025-12-23 Ø5.0mm x L10.0mm, Conical Connection, Regular Platform
D824FRC50110 - Fixation One2025-12-23 Ø5.0mm x L11.5mm, Conical Connection, Regular Platform
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