Macro-Wedges

GUDID E29950300

assorted

Polydentia SA

Dental wedge, single-use
Primary Device IDE29950300
NIH Device Record Key548a0a45-6703-4a31-964b-9dbeb74714c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacro-Wedges
Version Model Number5030
Company DUNS481461598
Company NamePolydentia SA
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 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
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
Phone+41919462948
Emailinfo@polydentia.ch
Phone+41919462948
Emailinfo@polydentia.ch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29950300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-07-11
Device Publish Date2022-07-01

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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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