Temporary Abutment Plastic Cap, Soft

GUDID D824TABPC30

Red Plastic Cap, Soft Rigidity, Fits On Temporary Abutment

SURGIKOR, LLC

Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece
Primary Device IDD824TABPC30
NIH Device Record Keyc80715aa-2372-41e3-b92d-04cddfd32f0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTemporary Abutment Plastic Cap, Soft
Version Model NumberTABPC3
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
HIBCCD824TABPC30 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D824TABPC30]

Moist Heat or Steam Sterilization


[D824TABPC30]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-31

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