Unica Proximal 6914

GUDID E29969149

anterior matrices

Polydentia SA

Dental matrix band, single-use
Primary Device IDE29969149
NIH Device Record Keyd6d3829c-8642-4b14-977a-e18d889877ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnica Proximal
Version Model Number6914
Catalog Number6914
Company DUNS481461598
Company NamePolydentia SA
Device Count50
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE29969140 [Primary]
HIBCCE29969149 [Unit of Use]

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 Date2025-05-07
Device Publish Date2025-04-29

On-Brand Devices [Unica Proximal ]

E29969149anterior matrices
E29969139anterior matrices

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