ACRY PLUS EVO RX 0120048

GUDID 08056865012483

ACRY PLUS EVO RX 6 LOWER

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID08056865012483
NIH Device Record Key0bafc094-42a0-493a-af25-9eb03205902c
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY PLUS EVO RX
Version Model NumberACRY PLUS EVO RX 6 LOWER
Catalog Number0120048
Company DUNS435782248
Company NameDENTAL MANUFACTURING SPA
Device Count6
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
GS108056865012483 [Primary]
GS118056865012480 [Unit of Use]
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.