ACRY PLUS V. 0120022

GUDID 18056865012220

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID18056865012220
NIH Device Record Keyd4c10eec-baf4-48fe-971d-d100fe7cb40a
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY PLUS V.
Version Model NumberACRY PLUS V. 8 UPPER
Catalog Number0120022
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
GS108056865012223 [Primary]
GS118056865012220 [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 Date2020-02-27
Device Publish Date2020-02-19

On-Brand Devices [ACRY PLUS V. ]

18056865012237ACRY PLUS V. 8 LOWER
18056865012220ACRY PLUS V. 8 UPPER
18056865012213ACRY PLUS V. 6 LOWER
18056865012206ACRY PLUS V. 6 UPPER

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