maximat plus spools

GUDID E29951219

Polydentia SA

Dental matrix band, single-use
Primary Device IDE29951219
NIH Device Record Key92f43149-122c-4fa4-95a8-4f4a7a69c8eb
Commercial Distribution StatusIn Commercial Distribution
Brand Namemaximat plus spools
Version Model Number5122
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch
Phone+4199462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29951210 [Primary]
HIBCCE29951219 [Unit of Use]
HIBCCE29951220 [Primary]

FDA Product Code

DZNInstruments, Dental Hand

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by Polydentia SA

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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