ACRY PLUS EVO RX 0120049

GUDID 08056865012490

ACRY PLUS EVO RX 8 UPPER

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID08056865012490
NIH Device Record Keyd2849950-9204-43a3-aba8-0e159ec402e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY PLUS EVO RX
Version Model NumberACRY PLUS EVO RX 8 UPPER
Catalog Number0120049
Company DUNS435782248
Company NameDENTAL MANUFACTURING SPA
Device Count8
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056865012490 [Primary]
GS118056865012497 [Unit of Use]
GS128056865012494 [Package]
Package: [12 Units]
In Commercial Distribution
GS128056865012906 [Unit of Use]

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

On-Brand Devices [ACRY PLUS EVO RX ]

08056865012506ACRY PLUS EVO RX 8 LOWER
08056865012490ACRY PLUS EVO RX 8 UPPER
08056865012483ACRY PLUS EVO RX 6 LOWER
08056865012476ACRY PLUS EVO RX 6 UPPER

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