myRing Prime 6891

GUDID E29968919

Polydentia SA

Dental matrix band retainer
Primary Device IDE29968919
NIH Device Record Keyc9282e8a-25d2-414b-ab19-c5c1d0c681f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyRing Prime
Version Model Number6891
Catalog Number6891
Company DUNS481461598
Company NamePolydentia SA
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29968910 [Primary]
HIBCCE29968919 [Unit of Use]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


[E29968919]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-24
Device Publish Date2025-06-16

Devices Manufactured by Polydentia SA

E29950029 - wood wedges2025-06-24
E2995018MN9 - Orange wood wedges2025-06-24
E2995018PLUS9 - Orange wood wedges2025-06-24
E2995018S9 - Orange wood wedges2025-06-24
E29968900 - myQuickmat Prime Kit2025-06-24
E29968919 - myRing Prime2025-06-24
E29968919 - myRing Prime2025-06-24
E29968929 - myTines Prime2025-06-24
E29968939 - Quickmat Prime2025-06-24

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