ACRY SMART 1ST 0120100

GUDID 18056865121007

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID18056865121007
NIH Device Record Key0a35a8db-aa99-426a-8ed2-b60aed73d192
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY SMART 1ST
Version Model NumberACRY SMART 1ST 6 UPPER
Catalog Number0120100
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
GS108056865121000 [Primary]
GS118056865121007 [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 Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [ACRY SMART 1ST ]

18056865121014ACRY SMART 1ST 6 LOWER
18056865121007ACRY SMART 1ST 6 UPPER

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