endo-stop

GUDID E29953019

opaque

Polydentia SA

Endodontic stopper
Primary Device IDE29953019
NIH Device Record Keye31d6aa6-205c-4b5f-828d-b4e4eace48a3
Commercial Distribution StatusIn Commercial Distribution
Brand Nameendo-stop
Version Model Number5301
Company DUNS481461598
Company NamePolydentia SA
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29953010 [Primary]
HIBCCE29953019 [Unit of Use]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


[E29953019]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-13
Device Publish Date2022-07-05

On-Brand Devices [endo-stop]

E29953100assorted
E29953089red-brown
E29953079black
E29953069green
E29953059blue
E29953049red
E29953039yellow
E29953029white
E29953019opaque

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.