TSI/ERI Abutment Screw AS 4100 TSI

GUDID D785AS4100TSI0

TSI/ERI Abutment Screw 4.0/5.0mm

OCO BIOMEDICAL INC

Dental implant suprastructure, permanent, preformed
Primary Device IDD785AS4100TSI0
NIH Device Record Key7b20e602-181d-4248-bab7-ddf464f817f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameTSI/ERI Abutment Screw
Version Model NumberAbutment Screw for 4.0/5.0mm TSI/ERI
Catalog NumberAS 4100 TSI
Company DUNS094146123
Company NameOCO BIOMEDICAL INC
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
HIBCCD785AS4100TSI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


[D785AS4100TSI0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-07
Device Publish Date2024-04-29

On-Brand Devices [TSI/ERI Abutment Screw]

D785AS4100TSI0TSI/ERI Abutment Screw 4.0/5.0mm
D785AS3100TSI0TSI/ERI Abutment Screw 3.25mm

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