myTines GO 6307

GUDID E29963079

extremities for myClip 2.0 and myRing Forte

Polydentia SA

Dental matrix band retainer
Primary Device IDE29963079
NIH Device Record Key9383ecd6-81f2-4746-895f-9f85b0c2139b
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyTines GO
Version Model Number6307
Catalog Number6307
Company DUNS481461598
Company NamePolydentia SA
Device Count12
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

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29963070 [Primary]
HIBCCE29963079 [Unit of Use]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


[E29963079]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-27
Device Publish Date2024-08-19

Devices Manufactured by Polydentia SA

E29963079 - myTines GO2024-08-27extremities for myClip 2.0 and myRing Forte
E29963079 - myTines GO2024-08-27 extremities for myClip 2.0 and myRing Forte
E29958059 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm premolar
E29958069 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm molar
E29958359 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm premolar
E29958369 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm molar
E29958469 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm molar deep
E29958569 - QuickmatFIT 2024-02-06 anatomical sectional matrices 0.04mm molar deep
E29910989 - QuickmatFLEX sectional matrices2023-08-31 0.03 mm / 6.4 mm 10 pcs.

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